The following procedures shall apply with regard to the suspension of a conformity

assessment body listed in a Sectoral Annex:

a) A Party shall notify the other Party of its contestation of the technical competence or compliance of a conformity assessment body listed in a Sectoral Annex and the contesting Party's intent to suspend such conformity assessment body. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other Party;

b) The conformity assessment body shall be given prompt notice by the other Party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation;

c) Any such contestation shall be discussed between the Parties in the relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the conformity assessment body shall be suspended;

d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the Party in whose territory the body in question is located, but may be carried out jointly by the Parties in justified cases;

e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the conformity assessment body shall be suspended upon the request of the contesting Party;

f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognize the results of conformity assessment procedures performed by that conformity assessment body subsequent to suspension. A Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to suspension, unless a Regulatory Authority of the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex; and

g) The suspension shall remain in effect until agreement has been reached by the Parties upon the future status of that body.

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.

1. This Agreement including its Sectoral Annexes on Telecommunications Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical GMP Inspections, and Medical Devices shall enter into force on the first day of the second month following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of this Agreement.
2. This Agreement including any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 30 days following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the Sectoral Annex.
3. Either Party may terminate this Agreement in its entirety or any individual Sectoral Annex thereof by giving the other Party six months notice in writing. In the case of termination of one or more Sectoral Annexes, the Parties will seek to achieve by consensus to amend this Agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this Article. Failing such consensus, the Agreement shall terminate at the end of six months.
4. Following termination of the Agreement in its entirety or any individual Sectoral Annex thereof, a Party shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under this Agreement prior to termination, unless a Regulatory Authority in the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.

1. The Sectoral Annexes referred to in Article 21.1, as well as any New Sectoral Annexes added pursuant to Article 21.2, shall form an integral part of this Agreement.
2. For a given product or sector, the provisions contained in the relevant Sectoral Annexes shall apply in the first place, and the provisions of this text in addition to those provisions. In the case of any inconsistency between the provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of that inconsistency.
3. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement.
4. In the case of the Sectoral Annex on Medical Devices, the Parties shall review the status of such Annex at the end of three years from entry into force.

This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic. In the event of inconsistencies of interpretation, the English text shall be determinative.

DONE at ____ this ___day of ___, 1997.

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community,

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS

EC U.S.

SECTION II

SCOPE AND COVERAGE

1. This Sectoral Annex shall apply to equipment, interfaces, and services subject to Section I. In general terms the provisions of this Sectoral Annex shall apply to the following types of telecommunications terminal equipment, satellite terminal equipment, radio transmitters, and information technology equipment:

(a) equipment intended for connection to the public telecommunications network in order to send, process or receive information, whether the equipment is to be connected directly to the "termination" of the network or to inter-work with such a network, being connected directly or indirectly to the termination point. The system of connection may be wire, radio, optical or other electro-magnetic means;

(b) equipment capable of being connected to a public telecommunications network even if it is not its intended purpose, including information technology equipment having a communication port; and

(c) all radio transmitters subject to an equipment authorization procedure by either Party.

2. The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex:

SECTION II (continued)

SCOPE AND COVERAGE

EC U.S.

Note: A list of acronyms and a glossary is contained in Appendix 1 to this Sectoral Annex.

SECTION III

CONFORMITY ASSESSMENT PROCEDURES

FOR TELECOMMUNICATION EQUIPMENT

1. Description of Mutual Recognition Obligations

In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V shall be recognized by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.

2. Conformity Assessment Procedures

Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognizes that the conformity assessment bodies of the other Party, listed in Section V, are authorized to perform the following procedures with regard to the importing Party's technical requirements for telecommunications terminal equipment, satellite terminal equipment, radio transmitters or information technology equipment:

a) testing and issuing of test reports;

b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex; and

c) performing quality assurance certification pursuant to Council Directive 91/263/EEC.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V

EC U.S.

SECTION V

CONFORMITY ASSESSMENT BODIES

EC U.S.

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V

EC U.S.

SECTION VII

ADDITIONAL PROVISIONS

1. SUB - CONTRACTING

1.1Any sub-contracting by conformity assessment bodies shall be in accordance with the sub- contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC.

1. 2The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub- contracting. These details will be available to the other Party on request.
2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT

2.1For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.

2.2Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like-domestic goods.

3. JOINT SECTORAL COMMITTEE

3.1A combined Joint Sectoral Committee for this Sectoral Annex and the EMC Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the EMC Sectoral Annexes. The JSC shall determine its own rules of procedure.

3.2The JSC consists of representatives of the U.S. and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the U.S. shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the U.S. or EC representative may raise the matter in the Joint Committee.

3.3The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:

a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;

b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;

c) advising the Parties on matters relating to this Sectoral Annex; and

d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

4. CONTACT POINT

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations, and complaints under this Sectoral Annex.

5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX

In the event that there are changes to the legislative, regulatory, and administrative provisions referenced in Section I or the introduction of new legislative, regulatory, and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes.

SECTION VIII

TRANSITIONAL ARRANGEMENT

1. There shall be a transitional period of 24 months.
2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and an understanding of each other's system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transitional arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon successful completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V of the exporting country shall be accepted by the importing Party.
3. This transitional period shall be used by the Parties:

a) to consider new legislative changes needed to support the objectives of the Agreement;

b) to initiate regulatory changes needed to support the objectives of the Agreement;

c) to exchange information on and develop better understanding of their respective regulatory requirements;

d) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and

e) to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.

4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.

5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:

a) on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;

b) the applicant is informed in a precise and complete manner of any deficiency;

c) any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; and

d) procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.

6. Each Party ensures that issuance of approvals, certificates, or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.

7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.

8. The Parties may jointly sponsor two seminars, one in the U.S. and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.

9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex.

APPENDIX 1

LISTS OF ACRONYMS AND GLOSSARY

ACTE Approvals Committee for Terminal Equipment

ADLNBAssociation of Designated Laboratories and Notified Bodies

CAB Conformity Assessment Body

CFR U.S. Code of Federal Regulations, Title 47 CFR

CTR Common Technical Regulation

EC European Community

EEC European Economic Community

EN Norme Européenne (European Standard)

EU European Union

FCC Federal Communications Commission

IEC International Electrotechnical Commission

ISDN Integrated Services Digital Network

ISO International Standards Organization

ITU International Telecommunications Union

MRA Mutual Recognition Agreement

MS Member States (of the European Union)

NB Notified Bodies

NIST National Institute of Standards and Technology

OJ Official Journal (of the European Union)

ONP Open Network Provision

PSTN Public Switched Telephone Network

STG Sectoral Technical Group for Telecommunications

TBR Technical Basis for Regulation

X21 ITU-T Recommendation X21

X25 ITU-T Recommendation X25

PREAMBLE

Recognizing that this Annex constitutes a Sectoral Annex to the framework Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS

EC U.S.

SECTION II

SCOPE AND COVERAGE

EC U.S.

SECTION III

CONFORMITY ASSESSMENT PROCEDURES

FOR EQUIPMENT IDENTIFIED IN SECTION II

1. Description of Mutual Recognition Obligations

In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V, shall be recognized by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.

2. Conformity Assessment Procedures

Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognizes that the conformity assessment bodies of the other Party, listed in Section V, are authorized to perform the following procedures with regard to the importing Party's technical requirements for equipment identified in Section II:

a) testing and issuing of test reports;

b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V

EU U.S.

SECTION V

CONFORMITY ASSESSMENT BODIES

EC U.S.

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V

EC U.S.

SECTION VII

ADDITIONAL PROVISIONS

1. SUB - CONTRACTING

1.1 Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC.

1. 2 The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its subcontractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.
2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT

2.1 For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.

2.2 Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3 The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like-domestic goods.

3. JOINT SECTORAL COMMITTEE

3.1 A combined Joint Sectoral Committee for this Sectoral Annex and the Telecommunications Equipment Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the Telecommunications Equipment Sectoral Annex. The JSC shall determine its own rules of procedure.

3.2 The JSC consists of representatives of the U.S. and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the U.S. shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the U.S. or EC representatives may raise the matter in the Joint Committee.

3.3 The JSC may address any matter related to the effective functioning of this Sectoral Annex, including :

a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;

b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures.

c) advising the Parties on matters relating to this Sectoral Annex;

d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

4. CONTACT POINT

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints under this Sectoral Annex.

5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX

In the event that there are changes to the legislative, regulatory and administrative provisions referenced in Section I or the introduction of new legislative, regulatory and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes.

SECTION VIII

TRANSITIONAL ARRANGEMENT

1. There shall be a transitional period of 24 months.
2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and understanding of each others system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transition arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V shall be accepted by the importing Party.
3. This transitional period shall be used by the Parties :

a)to consider new legislative changes needed to support the objectives of the Agreement;

b) to initiate regulatory changes needed to support the objectives of the Agreement;

c) to exchange information on and develop better understanding of their respective regulatory requirements;

d) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and

e) to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.

4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.

5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:

• on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;
• the applicant is informed in a precise and complete manner of any deficiency;
• any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards;
• procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance;

6. Each Party ensures that issuance of approvals, certificates or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.

7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.

8. The Parties may jointly sponsor two seminars, one in U.S. and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.

9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex.

FOR

ELECTRICAL SAFETY

PREAMBLE

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS

SECTION II

SCOPE AND COVERAGE

EC U.S.

SECTION III

Description of Mutual Recognition Obligations

In accordance with the provisions of the Agreement, EC conformity assessment bodies listed in Section V of this Annex shall be recognized to test, certify and mark products within the scope of their NRTL recognition for assessing conformity to U.S. requirements.

With regard to U.S. conformity assessment bodies listed in Section V of this Annex, in the event of a challenge within the European Community under Article 8.2 of Council Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity assessment bodies shall be accepted by the European Community Authorities in the same way that reports from European Community Notified Bodies are accepted. That is, (listed conformity assessment bodies) in the U.S. shall be recognized under Article 11 of Council Directive 73/23/EEC as "bodies which may make a report in accordance with Article 8."

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V

SECTION V

CONFORMITY ASSESSMENT BODIES

[** An initial list of Conformity Assessment Bodies should be listed in this Section by the time we implement the Agreement.**]

SECTION VI

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING

CONFORMITY ASSESSMENT BODIES

SECTION VII

JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY

1. The Joint Sectoral Committee for Electrical Safety (JCS/ES) consists of representatives of the U.S. and the EC. OSHA shall represent the U.S. on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure.

2. The Joint Sectoral Committee may address any matter related to the effective functioning of this Sectoral Annex, including :

• Developing improved procedures and criteria for designation in order to facilitate the assessment and preparation of proposals by Designating Authorities, with a view towards expediting the period between designation and listing;
• providing a forum for discussion of issues that may arise concerning the implementation of this Sectoral Annex;
• advising the Parties on matters relating to this Sectoral Annex; and
• enhancing the operation of this Sectoral Annex.

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the Unites States and the European Community.

The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex.

To facilitate that purpose, a transitional period of eighteen months is arranged to build confidence as defined in this Sectoral Annex, Section 6.

SECTION 1

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS

1. For the European Community:

European Parliament and European Council Directive 94/25 EEC on the Approximation of the Laws, Regulations, and Administrative Provisions of the Member States Relating to Recreational Craft.

2. For the U.S.:

46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

SECTION 2

SCOPE AND COVERAGE

1. This Sectoral Annex applies to all recreational craft which in the European Community or the United States are subject to conformity assessment by a conformity assessment body or an approval procedure, as applicable, before being put on the market.
2. The product coverage for each Party shall be determined by the following relevant requirements:

(a) for the European Community:

Recreational craft as defined in Directive 94/25 EEC.

(b) for the United States:

Any product falling under the scope of 46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

3. The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply:

(a) for approvals to European Community requirements, conformity assessment bodies designated by the U.S. shall establish compliance as required to be demonstrated by Directive 94/25 EEC. This demonstration of compliance shall be recognized in the European Community and products so certified shall have

unrestricted access to the EC market for sale as recreational craft, pursuant to Section 1.

(b) for approvals to United States requirements, conformity assessment bodies designated by the European Community shall establish compliance as required to be demonstrated as set forth in paragraph 2(b) of this Section and products so certified shall have unrestricted access to the U.S. market for sale as recreational craft, pursuant to Section 1.

SECTION 3

AUTHORITIES RESPONSIBLE FOR DESIGNATING

THE CONFORMITY ASSESSMENT BODIES

1. For the European Community:

Member States Administrations as indicated in the Directive 94/25 EEC, Article 9.1.

2. For the United States:

National Institute of Standards and Technology (NIST).

SECTION 4

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING

CONFORMITY ASSESSMENT BODIES

1. For the purpose of this Sectoral Annex, each party shall designate competent conformity assessment bodies to carry out conformity assessment and approval to the requirements of the other Party. Such designation shall be carried out according to the procedures set out in Article 7 of the Agreement. A list of conformity assessment bodies together with the products and procedures for which they have been listed, is in Section 5 below.
2. Each Party agrees that the listed conformity assessment bodies comply with the requirements for such bodies established by the other Party. These are:

(a) for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25 EEC, are deemed to be in compliance with U.S. requirements;

(b) for the U.S., in accordance with the requirements set out in the regulations listed in Section 1, the conformity assessment bodies listed in Section 5 are designated by NIST using the evaluation procedures contained in the appropriate EN 45000 series of standards or the corresponding ISO/IEC Guides.

3. With regard to the designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex, the specific procedures in Articles 7, 8 and 9 of the Agreement shall be followed.

SECTION 5

CONFORMITY ASSESSMENT BODIES

1. European Community

The conformity assessment bodies designated by the European Community are those Notified Bodies which have been notified by the Member States of the Community, in accordance with Directive 94/25 EEC, and whose names and reference numbers have been published in the Official Journal of the European Communities.

2. United States

[To be provided by U.S.]

SECTION 6

TRANSITIONAL ARRANGEMENT

1. There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex.
2. The purpose of the transitional arrangement is to provide a means whereby the Parties to this Agreement can cooperate to establish a system for designating conformity assessment bodies and can mutually build confidence in the abilities of these bodies. Successful completion of this transitional arrangement is intended to result in a determination that conformity assessment bodies comply with the applicable criteria and to have the equipment approved by the conformity assessment bodies of the exporting country accepted by the approval authority of the importing country
3. During this transitional period, the parties shall:

(a) exchange information on technical data and conformity assessment criteria and procedures, thus developing greater familiarity with their respective regulatory requirements; and

(b) carry out or recommend any applicable policy, legislative and regulatory changes necessary for the provisions of this Annex.

4. Product Scope

All products covered by Section 2 of this Annex.

5. Cooperation

During this transitional period, both Parties shall endeavor to jointly sponsor seminars for the purpose of improving the understanding of technical specifications applicable in each Party's jurisdiction.

6. Inspections

Inspections or audits shall be permitted to verify compliance of conformity assessment bodies with their responsibilities under this Agreement. The scope of these inspections or audits shall be agreed upon in advance by both Parties.

SECTION 7

ADDITIONAL PROVISIONS

1. In accordance with the relevant provisions of the Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and shall regularly supply details of certifications issued in order to facilitate post market surveillance.
2. The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility may apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on Electrical Safety and Electromagnetic Compatibility apply.

SECTION 8

DEFINITIONS

"Notified Body", means a third party authorized to perform the conformity assessment tasks specified in Directive 94/25 EEC, which has been appointed by a Member State from the bodies falling within its jurisdiction. The Notified Body has the necessary qualifications to meet requirements laid down in Directive 94/25 EEC and has been notified to the Commission and to the other Member States.

EC-U.S. MRA

PREAMBLE

Recognizing that this Annex constitutes a Sectoral Annex to the framework Agreement on Mutual Recognition between the United States and the European Community.

Definitions, Purpose, Scope and Coverage

Article 1

Definitions

1. "Equivalence" of the regulatory systems means that the systems are sufficiently comparable to assure that the process of inspection and the ensuing inspection reports will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. "Equivalence" does not require that the respective regulatory systems have identical procedures.
2. "Enforcement" means action taken by an authority to protect the public from products of suspect quality, safety and efficacy or to assure that products are manufactured in compliance with appropriate laws, regulations, standards and commitments made as part of the approval to market a product.
3. "Good Manufacturing Practices" :(tentative merging of US and EC concepts to be revisited)

GMPs mean the requirements found in the respective legislations, regulations, and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to process.

GMPs are that part of quality assurance which ensures that products are consistently produced and controlled to quality standards. For the purpose of this Annex, GMPs include therefore the system whereby the manufacturer receives the specifications of the product and/or process from the Marketing Authorization/Product Authorization or License holder or applicant and ensures the product is made in compliance with its specifications (Qualified Person certification in the EC).

4."Inspection" means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practices and/or commitments made as part of the approval to market a product.

5."Inspection Report" means the written observations and Good Manufacturing Practices compliance assessment completed by an authority listed in Appendix 2.

6."Regulatory System" means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.

Article 2

Purpose

The provisions of this Annex govern the exchange between the Parties and normal endorsement by the receiving authority of official Good Manufacturing Practices (GMP) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the Parties, which is the cornerstone of this Annex.

Article 3

Scope

The provisions of this Annex shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community before products are marketed (hereafter referred to as "pre-approval inspections") as well as during their marketing (hereafter referred to as "post-approval inspections").

Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMP requirements.

Appendix 2 lists the authorities participating in activities under this Annex.

Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.

Article 4

Product coverage

These provisions will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the EU) and to drugs for human or animal use, biological products for human use , and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2.

Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals and medicinal gases are also excluded during the transition phase, their situation will be reconsidered at the end of the transition period. Products regulated by the Center for Biologics Evaluation and Research as devices are not covered under this Annex.

Appendix 3 contains an indicative list of products covered by this Annex.

Chapter 2

TRANSITION PERIOD

Article 5

Length of transition period

A three-year transition period will start immediately after the effective date of the Agreement.

Article 6

Equivalence assessment

1. The criteria to be used by the Parties to assess equivalence are listed in Appendix 4. Information pertaining to the criteria under Community competence will be provided by the Community.
2. The authorities of the parties will establish and communicate to each other their draft programs for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programs will be carried out, as deemed necessary by the authorities, for post- and pre-approval inspections and for various product classes or processes.
3. The equivalence assessment shall include information exchanges (including inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities' capabilities. In conducting the equivalence assessment, the Parties will ensure that efforts are made to save resources.
4. Equivalence assessment for authorities added to Appendix 2 after the effective date of this agreement will be conducted as described in this Annex, as soon as practicable.

Article 7

Participation in the equivalence assessment and determination

The authorities listed in Appendix 2 will actively participate in these programs to build a sufficient body of evidence for their equivalence determination. Both parties will exercise good faith efforts to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow.

Article 8

Other transition activities

As soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed inspection report format(s).

Chapter 3

End of transition period

Article 9

Equivalence determination

Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix 4, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g. post-approval or pre-approval) or product classes or processes.

The Parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.

Article 10

Authorities not listed as currently equivalent

Authorities not currently listed as equivalent, or not equivalent for certain types of inspections, product classes or processes may apply for reconsideration of their status once the necessary corrective measures have been taken or additional experience is gained.

Chapter 4

Operational period

Article 11

Start of the operational period

The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory.

In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the FDA will accept for normal endorsement (as provided in Article 12) inspection reports generated as a result of inspections conducted jointly by that authority on its territory and another authority listed as equivalent, provided that the authority of the Member State in which the inspection is performed can guarantee enforcement of the findings of the inspection report and require that corrective measures be taken when necessary. FDA has the option to participate in these inspections, and based on experience gained during the transition period, the Parties will agree on procedures for exercising this option.

In the EC, the qualified person will be relieved of responsibility for carrying the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.

Article 12

Nature of recognition of inspection reports

Inspection reports (containing information as established under Article 8), including a GMP compliance assessment, prepared by authorities listed as equivalent, will be provided to the authority of the importing Party. Based on the determination of equivalence in light of the experience gained, these inspection reports will normally be endorsed by the authority of the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in an inspection report, quality defects identified in the post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the authority of the importing Party may request clarification from the authority of the exporting Party which may lead to a request for re-inspection. The authorities will endeavor to respond to requests for clarification in a timely manner.

Where divergence is not clarified in this process, an authority of the importing country may carry out an inspection of the production facility.

Article 13

Transmission of post-approval inspection reports

Post-approval GMP inspection reports concerning products covered by this Annex will be transmitted to the authority of the importing country within 60 calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted 90 calendar days of the request.

Article 14

Transmission of pre-approval inspection reports

A preliminary notification that an inspection may have to take place will be made as soon as possible.

Within 15 calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In the EC, requests will be sent directly to the relevant authority, with a copy to the European Agency for the Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot carry out the inspection as requested, the requesting authority shall have the right to conduct the inspection.

Reports of pre-approval inspections will be sent within 45 calendar days of the request that transmitted the appropriate information and detailed the precise issues to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.

Article 15

Monitoring continued equivalence

Monitoring activities for the purpose of maintaining equivalence shall include review of the exchange of inspection reports and their quality and timeliness; performance of a limited number of joint inspections; and the conduct of common training sessions.

Article 16

Suspension

Each Party has the right to contest the equivalence of an authority. This right will be exercised in an objective and reasoned manner in writing to the other Party.

The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the JSC determines that verification of equivalence is required, it may be carried out jointly by the Parties in a timely manner, pursuant to Article 6.

Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended.

Upon the suspension of an authority previously listed as equivalent, a Party is no longer obligated to normally endorse the inspection reports of the suspended authority. A Party shall continue to normally endorse the inspection reports of that authority prior to suspension, unless the authority of the receiving party decides otherwise based on health or safety considerations. The suspension will remain in effect until unanimous consent has been reached by the Parties on the future status of that authority.

Chapter 5

Joint Sectoral Committee

Article 17

Role and composition of the Joint Sectoral Committee

A Joint Sectoral Committee is set up to monitor the activities under both the transitional and operational phases of this Annex.

The Committee will be co-chaired by a representative of FDA for the US and a representative of the EC who each will have one vote. Decisions will be taken by unanimous consent.

The Joint Sectoral Committee's functions will include:

1. making a joint assessment, which must be agreed by both Parties, of the equivalence of the respective authorities,
2. developing and maintaining the list of equivalent authorities, including any limitation in terms of inspecting type or products, and communicating the list to all authorities and the Joint Committee,
3. providing a forum to discuss issues relating to this Annex, including concerns that an authority may be no longer equivalent and opportunity to review product coverage,
4. consideration of the issue of suspension.

The Joint Sectoral Committee shall meet at the request of either Party and, unless the co-chairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee.

Chapter 6

Information exchange

Article 18

Regulatory collaboration

The Parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

The Parties shall notify each other in writing of any changes to Appendix 2.

Article 19

Information relating to quality aspects

The authorities will establish an appropriate means of exchanging information on any confirmed problem reports, corrective actions, recalls, rejected import consignments and other regulatory and enforcement problems for products subject to this Annex.

Article 20

Alert System

The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix 5.

Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.

Chapter 7

Safeguard clause

Article 21

Each Party recognizes that the importing country has a right to fulfill its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in Article 12.

***

APPENDIX 1

List of applicable laws, regulations and administrative provisions

For the European Community:

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended.

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended.

Council Directive 81/851/EEC of 6 November 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products as widened and amended.

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products

Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

Council Directive 25/92/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use & Guide to Good Distribution Practice

Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV.

For the United States :

Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act

Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799

Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.

APPENDIX 2

List of Authorities

United States

In the United States, the regulatory authority is the Food and Drug Administration.

European Community

In the European Community, the regulatory authorities are the following :

Austria: Bundesministerium Fur Arbeit, Gesundheit, und Soziales, Wien

Belgium: Ministèrie van Sociale Zakem, Volksgezondheid en Leefmilieu /Ministere des Affaires Sociales, Sante Publique et Environment/ Algemeine Farmaceutische Inspectie, Inspection Generale de la Pharmacie, Bruxelles,Brussel.

Denmark: Laegemiddelstryelsen, (Danish Medicines Agency), Brønshøj

Finland: Laakelaittos/Lakemedelsverket (National Agency for Medicines), Helsinki.

France: Agence du Médicament, Direction de l'inspection et des établissements, Saint Denis. (Human)

Agence Nationale du Médicament Vétérinaire, Fougères (Veterinary)

Germany: Bundesgesundheitsministerium, Bonn.

Paul-Ehrlich Institut, Langen (biologicals only)

Zustandige Behorden der 16 Bundeslander: Bayern, Berlin

Brandenberg, Bremen, Hamburg, Hessen, Niedersachsen, Nordrhein- Westfalen, Rheinland-Pfalz, Mecklenberg-Vorpommern, Saarland, Sachsen, Sachsenanhalt, Schleswog-Holstein, Thuringen.

Greece: Ministry of Health and Welfare, National Drug Organisation (E.O.F.), Athens.

Ireland: Irish Medicines Board, Dublin.

Italy: Ministero della Sanità, Dipartimento Farmaci e Farmacovigilanza, Roma. (Human)

Ministero della Sanità, Dipartimento alimenti e nutrizione e sanità pubblica veterinaria - Div. IX, Roma (Veterinary)

Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments, Luxembourg

The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie voor de Gezondheidszorg, Rijswijk

Portugal: Instituto da Farmácia e do Medicamento (INFARMED), Lisboa

Spain: Ministerio Sanidad y Consumo, Subdirección. General de Control Farmacéutico, Madrid. (Human)

Ministerio de Agricultura Pesca y Alimentación, Madrid, (Veterinary)

Sweden: Läkemedelsverket ( Medical Products Agency), Uppsala.

United Kingdom: Medicines Control Agency, London.

Veterinary Medicines Directorate, Addlestone.

European Union:European Commission, Brussels.

European Agency for the Evaluation of Medicinal Products (EMEA), London.

APPENDIX 3

Indicative list of Products covered by the Sectoral Annex

Recognizing that precise definition of medicinal products and drugs are to be found in the legislations referred to above, an indicative list of products covered by the agreement is given below:

• human medicinal products including prescription and non-prescription drugs;
• human biologicals including vaccines, and immunologicals;
• veterinary pharmaceuticals, including prescription and non-prescription drugs, with the exclusion of veterinary immunologicals;
• pre-mixes for the preparation of veterinary medicated feeds (EC), Type A medicated articles for the preparation of veterinary medicated feeds (US);
• intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals(US)/starting materials (EC).

APPENDIX 4

Criteria for Assessing Equivalence for Post- and Pre-Approval

I. Legal/Regulatory authority and structures and procedures providing for post- and pre- approval:

A. Appropriate statutory mandate and jurisdiction.

B. Ability to issue and update binding requirements on GMPs and guidance documents.

C. Authority to make inspections, review and copy documents, and to take samples and collect other evidence.

D. Ability to enforce requirements and to remove products found in violation of such requirements from the market.

E. Substantive current good manufacturing requirements.

F. Accountability of the regulatory authority.

G. Inventory of current products and manufacturers.

H. System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information relating to matters covered by this Sectoral Annex.

II.Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest.

III.Administration of the regulatory authority:

A. Standards of education/qualification and training.

B. Effective quality assurance systems measures to ensure adequate job performance.

C. Appropriate staffing and resources to enforce laws and regulations.

IV.Conduct of Inspections:

A. Adequate pre-inspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment.

B. Adequate conduct of inspection, including statutory access to facilities, effective response to refusals, depth and competence of evaluation of operations, systems, and documentation; collection of evidence; appropriate duration of inspection and completeness of written report of observations to firm management.

C. Adequate post-inspection activities, including completeness of inspectors' report, inspection report review where appropriate, and conduct of follow-up inspections and other activities where appropriate, assurance of preservation and retrieval of records .

V. Execution of regulatory enforcement actions to achieve corrections, designed to prevent future violations, and to remove products found in violation of requirements from the market.

VI.Effective Use of Surveillance Systems:

A. Sampling and analysis

B. Recall monitoring

C. Product defect reporting system

D. Routine surveillance inspections

E. Verification of approved manufacturing process changes to marketing authorizations/approved applications

VII. Additional specific criteria for pre-approval inspections

A. Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the authorities' capabilities.

B. Pre-inspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections.

C. Ability to verify chemistry, manufacturing and control data supporting an application is authentic and complete.

D. Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches.

E. Ability to verify conformity of the on site processes and procedures with those described in the application.

F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation.

APPENDIX 5

Elements to be Considered in Developing a Two-way Alert System

1. Documentation

• Definition of a crisis/emergency and under what circumstances an alert is required
• Standard Operating Procedures (SOPs)
• Mechanism of health hazards evaluation and classification
• Language of communication and transmission of information

2. Crisis Management System

• Crisis analysis and communication mechanisms
• Establishment of contact points
• Reporting mechanisms

3. Enforcement Procedures

• Follow-up mechanisms
• Corrective action procedures

4. Quality Assurance System

• Pharmacovigilance programme
• Surveillance/monitoring of implementation of corrective action

5. Contact points

For the purpose of this agreement, the contact points for the alert system will be:

for the European Community,

the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 4HB, England. Telephone +44-171-418 8400, Fax 418 8416.

for the United States :

UNITED STATES OF AMERICA - EUROPEAN COMMUNITY

MUTUAL RECOGNITION AGREEMENT OF

CONFORMITY ASSESSMENT

SECTORAL ANNEX ON

MEDICAL DEVICES

PREAMBLE

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Relation to Conformity Assessment (Agreement) between the United States (U.S.) and the European Community (EC),

Acknowledging that carrying out the provisions of this Annex will further public health protection, will be an important means of facilitating commerce in medical devices, and will lead to reduced costs for regulators and manufacturers of both Parties,

The Parties agree as follows:

CHAPTER 1

Purpose, Scope, and Coverage of the Sectoral Annex

Article 1

Purpose

1. The purpose of this Annex is to specify the conditions under which a Party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other Party with regard to medical devices as conducted by listed conformity assessment bodies (CABs) and to provide for other related cooperative activities.
2. This Annex is intended to evolve as programs and policies of the Parties evolve. The Parties will review this Annex periodically, in order to assess progress and identify potential enhancements to this Annex as FDA and EC policies evolve over time.

Article 2

Scope

1. The provisions of this Annex shall apply to the exchange and, where appropriate, endorsement of the following types of reports from CABs assessed to be equivalent:

a. Under the U.S. system, surveillance/post-market and initial/pre-approval inspection reports;

b. Under the U.S. system, premarket (510(k)) product evaluation reports;

c. Under the EC system, quality system evaluation reports; and

d. Under the EC system, EC type examination and verification reports.

Appendix 1 names the legislation, regulations, and related procedures under which: (a) products are regulated as medical devices by each Party; (b) CABs are designated and confirmed; and (c) these reports are prepared.

2. For purposes of this Annex, equivalence means that: CABs in the EC are capable of conducting product and quality systems evaluations against U.S. regulatory requirements in a manner equivalent to those conducted by FDA; and CABs in the U.S. are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CABs.

Article 3

Product Coverage

There are three components to this agreement each covering a discrete range of products:

1. Quality System Evaluations - U.S.-type surveillance/post-market and initial/pre-approval inspection reports and EC-type quality system evaluation reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.
2. Product Evaluation - U.S.-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the U.S. system as Class I/Class II - Tier 2 medical devices which are listed in Appendix 2.
3. Post-Market Vigilance Reports - Post-market vigilance reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.

Additional products and procedures may be made subject to this Annex by agreement of the Parties.

Article 4

Regulatory Authorities

The regulatory authorities shall have the responsibility of implementing the provisions of this Annex, including the designation and monitoring of CABs. Regulatory authorities are specified in Appendix 3. Each Party will promptly notify the other Party in writing of any change in the regulatory authority for a country.

CHAPTER 2

Transition Period

Article 5

Length and purpose of transition period

There will be a three-year transition period immediately following the date of entry into force of the Agreement. During the transition period, the Parties will engage in confidence- building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of CABs of the other Party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this Annex.

Article 6

Listing of CABs

Each Party shall designate CABs to participate in confidence-building activities by transmitting to the other Party a list of CABs which meet the criteria for technical competence and independence, as identified in Appendix 1. The list shall be accompanied by supporting evidence. Designated CABs will be listed in Appendix 4 for participation in the confidence building activities once confirmed by the importing Party. Non- confirmation would have to be justified based on documented evidence.

Article 7

Confidence Building Activities

1. At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to provide sufficient evidence of the capabilities of the designated CABs to perform quality system or product evaluations to the specifications of the Parties.
2. The joint confidence building program should include the following actions and activities:

a. Seminars designed to inform the Parties and CABs about each Party's regulatory system, procedures, and requirements;

b. Workshops designed to provide the Parties with information regarding requirements and procedures for the designation and surveillance of CABs;

c. Exchange of information about reports prepared during the transition period;

d. Joint training exercises; and

e. Observed inspections.

3. During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem.

4. Both Parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the Parties allow.

5. Both the EC and the U.S. will each prepare annual progress reports which will describe the confidence building activities undertaken during each year of the transition period. The form and content of the reports will be determined by the Parties through the Joint Sectoral Committee.

Article 8

Other transition period activities

1. During the transition period, the Parties will jointly determine the necessary information which must be present in quality system and product evaluation reports.
2. The Parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the Parties of the importing country) or suspension of the distribution of the product.

CHAPTER 3

End of transition period

Article 9

Equivalence Assessment

1. In the final six months of the transition period, the Parties shall proceed to a joint assessment of the equivalence of the CABs that participated in the confidence building activities. CABs will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CABs may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this Annex and with regard to any type of product covered by this Annex. The parties shall develop a list contained in Appendix 5 of CABs determined to be equivalent which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation.
2. The Parties shall allow CABs not listed for participation in the MRA, or listed for participation only as to certain types of evaluations, to apply for participation in this MRA once the necessary measures have been taken or sufficient experience has been gained, in accordance with Article 18.
3. Decisions concerning the equivalence of CABs must be agreed to by both Parties.

CHAPTER 4

Operational Period

Article 10

Start of the operational period

1. The operational period will start at the end of the transition period after the Parties have developed the list of CABs found to be equivalent. The provisions of this Chapter will apply only with regard to listed CABs and only to the extent of any specifications and limitations contained on the list with regard to a CAB.
2. The operational period will apply to quality system evaluation reports and product evaluation reports generated by CABs listed in accordance with this Annex for the evaluations performed in the respective territories of the Parties, except if the Parties agree otherwise.

Article 11

Exchange and endorsement of quality system evaluation reports

1. Listed EC CABs will provide FDA with reports of quality system evaluations, as follows:

a. For pre-approval quality system evaluations, EC CABs will provide full reports; and

b. For surveillance quality system evaluations, EC CABs will provide abbreviated reports.

2. Listed U.S. CABs will provide to the EC Notified Body of the manufacturer's choice:

a. Full reports of initial quality system evaluations;

b. Abbreviated reports of quality systems surveillance audits.

3. If the abbreviated reports do not provide sufficient information, the importing Party may request additional clarification from the CAB.

4. Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for re-inspection. The Parties will endeavor to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing Party may carry out the quality system evaluation.

Article 12

Exchange and endorsement of product evaluation reports

1. EC CABs listed for this purpose will, subject to the specifications and limitations on the list, provide to the FDA 510(k) premarket notification assessment reports prepared to U.S. medical device requirements.
2. U.S. CABs will, subject to the specifications and limitations on the list, provide to the EC notified body of the manufacturer's choice, type examination and verification reports prepared to EC medical device requirements.
3. Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for a re- evaluation. The parties will endeavor to respond to requests for clarification in a timely manner. Endorsement remains the responsibility of the importing Party.

Article 13

Transmission of quality system evaluation reports

Quality system evaluation reports covered by Article 11 concerning products covered by this Annex shall be transmitted to the importing Party within 60 calendar days of a request by the importing Party. Should a new inspection be requested the time period shall be extended by an additional 30 calendar days. A Party may request a new inspection, for cause, identified to the other Party. If the exporting Party cannot perform an inspection within a specified period of time, the importing Party may perform an inspection on its own.

Article 14

Transmission of product evaluation reports

Transmission of product evaluation reports will take place according to the importing Party's specified procedures.

Article 15

Monitoring continued equivalence

Monitoring activities will be carried out in accordance with Article 10 of the Agreement.

Article 16

Listing of Additional CABs

1. During the operational phase, additional CABs will be considered for equivalence using the procedures and criteria described in Articles 6, 7, and 9 of this Annex, taking into account the level of confidence gained in the overall regulatory system of the other Party.
2. Once a designating authority considers that such CABs, having undergone the procedures of Articles 6, 7, and 9 of this Annex, may be determined to be equivalent, it will then designate those bodies on an annual basis. Such procedures satisfy the procedures of Article 7(a) and (b) of the Agreement.
3. Following such annual designations, the procedures for confirmation of CABs under Articles 7(c) and (d) of the Agreement shall apply.

Chapter 5

Joint Sectoral Committee

Article 17

Role and composition of the Joint Sectoral Committee

1. A Joint Sectoral Management Committee is set up to monitor the activities under both the transitional and operational phases of this Annex.
2. The Committee will be co-chaired by a representative of the FDA for the U.S. and a representative of the EC who will each have one vote. Decisions will be taken by unanimous consent.
3. The JSC's functions will include:

a. making a joint assessment of the equivalence of CABs;

b. developing and maintaining the list of equivalent CABs, including any limitation in terms of their scope of activities and communicating the list to all authorities and the Joint Committee;

c. providing a forum to discuss issues relating to this Annex, including concerns that a CAB may no longer be equivalent and opportunity to review product coverage; and

d. consideration of the issue of suspension.

Chapter 6

Harmonization and Information Exchange

Article 18

Harmonization

During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonization Task Force and utilize the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonization Task Force and jointly determining whether they are applicable to the implementation of this Agreement.

Article 19

Regulatory cooperation

The Parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

The Parties shall notify each other in writing of any changes to Appendix 1.

Article 20

Alert system and exchange of post-market vigilance reports

1. An alert system will be set up during the transition period and maintained thereafter by which the Parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix to be attached to this Sectoral Annex. As part of that system, each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.
2. Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.

APPENDIX 1

Relevant Legislation, Regulations and Procedures

1. For the European Union the following legislation applies to Article 2 paragraph 1:

a. Council Directive 901385/EEC of 20 June 1990 on active implantable medical devices

-OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment procedures.

*Annex 2 (with the exception of section 4)

• Annex 4
• Annex 5

b. Council Directive 93142/EEC of 14 June 1993 on Medical Devices OJ No. L 169,12.7.1993, p.1. Conformity assessment procedures.

• Annex 2 (with the exception of section 4)
• Annex 3
• Annex 4
• Annex 5
• Annex 6

2. For the United States, the following legislation applies to Article 2 paragraph 1:

a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 321 et seq.

b. The Public Health Service Act, 42 U.S.C. §§ 201 et seq.

c. Regulations of the United States Food and Drug Administration found at 21 C.F.R., in particular, Parts 800 to 1299.

d. Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996).

APPENDIX 2

Scope of Product Coverage

1. Initial Coverage of the Transition Period

Upon entry into force of this Annex,(1) products qualifying for the transitional arrangements under this Agreement include:

a. All Class I products requiring premarket evaluations in the United States - see Table 1.

b. Those Class II products listed in Table 2.

2. During the Transition Period

The Parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows:

a. Those for which review may be based primarily on written guidance which the Parties will use their best efforts to prepare expeditiously; and

b. Those for which review may be based primarily on international standards, in order for the Parties to gain the requisite experience.

The corresponding additional product lists will be phased in on an annual basis. The Parties may consult with industry and other interested Parties in determining which products will be added.

3. Commencement of the Operational Period

a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period.

b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with the FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third-party review is available in the U.S..

4. Unless explicitly included by joint decision of the Parties, this agreement does not cover any U.S. Class II -tier 3 or any Class III product under either system.

TABLE 1

CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS

IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSISTION PERIOD

TABLE 1: CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES

ANESTHESIOLOGY PANEL (868)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

868.1910 ESOPHAGEAL STETHOSCOPE

BZW - STETHOSCOPE, ESOPHAGEAL

868.5620 BREATHING MOUTHPIECE

BYP - MOUTHPIECE, BREATHING

868.5640 MEDICINAL NONVENTILATORY NEBULIZER (ATOMIZER)

CCQ - NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

868.5675 REBREATHING DEVICE

BYW - DEVICE, REBREATHING

868.5700 NONPOWERED OXYGEN TENT

FOG - HOOD, OXYGEN, INFANT

BYL - TENT, OXYGEN

868.6810 TRACHEOBRONCHIAL SUCTION CATHETER

BSY - CATHETERS, SUCTION, TRACHEOBRONCHIAL

CARDIOVASCULAR PANEL

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

(NONE)

DENTAL PANEL (872)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

872.3400 KARAYA AND SODIUM BORATE WITH OR WITHOUT ACACIA DENTURE ADHESIVE

KOM - ADHESIVE, DENTURE, ACACIA AND KARAYA WITH SODIUM BORATE

872.3700 DENTAL MERCURY (U.S.P)

ELY - MERCURY

872.4200 DENTAL HANDPIECES AND ACCESSORIES

EBW - CONTROLLER, FOOD, HANDPIECE AND CORD

EFB - HANDPIECE, AIR-POWERED, DENTAL

EFA - HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

EGS - HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

EKX - HANDPIECE, DIRECT DRIVE, AC-POWERED

EKY - HANDPIECE, WATER-POWERED

872.6640 DENTAL OPERATIVE UNIT

EIA - UNIT, OPERATIVE DENTAL

EAR, NOSE, AND THROAT PANEL (874)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

874.1070 SHORT INCREMENT SENSITIVITY INDEX (SISI) ADAPTER

ETR - ADAPTER, SHORT INCREMENT SENSITIVITY INDEX (SISI)

874.1500 GUSTOMETER

ETM - GUSTOMETER

874.1800 AIR OR WATER CALORIC STIMULATOR

KHH - STIMULATOR, CALORIC-AIR

ETP - STIMULATOR, CALORIC-WATER

874.1925 TOYNBEE DIAGNOSTIC TUBE

ETK - TUBE, TOYNBEE DIAGNOSTIC

874.3300 HEARING AID

LRB - FACE PLATE HEARING-AID

ESD - HEARING-AID, AIR-CONDUCTION

874.4100 EPISTAXIS BALLOON

EMX - BALLOON, EPISTAXIS

874.5300 ENT EXAMINATION AND TREATMENT UNIT

ETF - UNIT, EXAMINING/TREATMENT, ENT

874.5550 POWERED NASAL IRRIGATOR

KMA - IRRIGATOR, POWERED NASAL

874.5840 ANTISTAMMERING DEVICE

KTH - DEVICE, ANTI-STAMMERING

GASTROENTEROLOGY - UROLOGY PANEL (876)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

876.5160 UROLOGICAL CLAMPS FOR MALES

FHA - CLAMP, PENILE

876.5210 ENEMA KIT

FCE - KIT, ENEMA, (FOR CLEANING PURPOSE)

876.5250 URINE COLLECTOR AND ACCESSORIES

FAQ - BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE

GENERAL HOSPITAL PANEL (880)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

880.5270 NEONATAL EYE PAD

FOK - PAD, NEONATAL EYE

880.5420 PRESSURE INFUSOR FOR I.V. BAG

KZD - INFUSOR, PRESSURE, FOR I.V. BAGS

880.5680 PEDIATRIC POSITION HOLDER

FRP - HOLDER, INFANT POSITION

880.6250 PATIENT EXAMINATION GLOVE

LZB - FINGER COT

FMC - GLOVE, PATIENT EXAMINATION

LYY - GLOVE, PATIENT EXAMINATION, LATEX

LZA - GLOVE, PATIENT EXAMINATION, POLY

LZC - GLOVE, PATIENT EXAMINATION, SPECIALITY

LYZ - GLOVE, PATIENT EXAMINATION, VINYL

880.6375 PATIENT LUBRICANT

KMJ - LUBRICANT, PATIENT

880.6760 PROTECTIVE RESTRAINT

BRT - RESTRAINT, PATIENT, CONDUCTIVE

FMQ - RESTRAINT, PROTECTIVE

NEUROLOGY PANEL (882)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

882.1030 ATAXIAGRAPH

GWW - ATAXIAGRAPH

882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER

GWS - ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL

882.4060 VENTRICULAR CANNULA

HCD - CANNULA, VENTRICULAR

882.4545 SHUNT SYSTEM IMPLANTATION INSTRUMENT

GYK - INSTRUMENT, SHUNT SYSTEM IMPLANTATION

882.4650 NEUROSURGICAL SUTURE NEEDLE

HAS - NEEDLE, NEUROSURGICAL SUTURE

882.4750 SKULL PUNCH

GXJ - PUNCH, SKULL

OBSTETRICS AND GYNECOLOGY PANEL

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

(NONE)

OPHTHALMOLOGY PANEL (886)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

886.1780 RETINOSCOPE

HKM - RETINOSCOPE, BATTERY-POWERED

886.1940 TONOMETER STERILIZER

HKZ - STERILIZER, TONOMETER

886.4070 POWERED CORNEAL BURR

HQS - BURR, CORNEAL, AC-POWERED

HOG - BURR, CORNEAL, BATTERY-POWERED

HRG - ENGINE, TREPHINE, ACCESSORIES, AC-POWERED

HFR - ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED

HLD - ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED

886.4300 KERATOME

HNO - KERATONE, AC-POWERED

HMY - KERATONE, BATTERY-POWERED

886.5850 SUNGLASSES (NON-PRESCRIPTION)

HQY - SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)

ORTHOPEDIC PANEL (888)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

888.1500 AC-POWERED GONIOMETER

KQX - GONIOMETER, AC-POWERED

888.4150 CALIPERS FOR CLINICAL USE

KTZ - CALIPER

PHYSICAL MEDICINE PANEL (890)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

890.3850 MECHANICAL WHEELCHAIR

LBE - STROLLER, ADAPTIVE

IOR - WHEELCHAIR, MECHANICAL

890.5180 MANUAL PATIENT ROTATION BED

INY - BED, PATIENT ROTATION, MANUAL

890.5710 HOT OR COLD DISPOSABLE PACK

IMD - PACK, HOT OR COLD, DISPOSABLE

RADIOLOGY PANEL (892)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

892.1100 SCINTILLATION GAMMA CAMERA

IYX - CAMERA, SCINTILLATION (GAMMA)

892.1110 POSITRON CAMERA

IZC - CAMERA, POSITRON

892.1300 NUCLEAR RECTILINEAR SCANNER

IYW - SCANNER, RECTILINEAR, NUCLEAR

892.1320 NUCLEAR UPTAKE PROBE

IZD - PROBE, UPTAKE, NUCLEAR

892.1330 NUCLEAR WHOLE BODY SCANNER

JAM - SCANNER, WHOLE BODY, NUCLEAR

892.1410 NUCLEAR ELECTROCARDIOGRAPH SYNCHRONIZER

IVY - SYNCHRONIZER, ELECTROCARDIOGRAPH, NUCLEAR

892.1890 RADIOGRAPHIC-FILM ILLUMINATOR

IXC - ILLUMINATOR, RADIOGRAPHIC-FILM

JAG - ILLUMINATOR, RADIOGRAPHIC-FILM, EXPLOSION-PROOF

892.1910 RADIOGRAPHIC GRID

IXJ -GRID, RADIOGRAPHIC

892.1960 RADIOGRAPHIC INTENSIFYING SCREEN

WAM - SCREEN, INTENSIFYING, RADIOGRAPHIC

892.1970 RADIOGRAPHIC ECG/RESPIRATOR SYNCHRONIZER

IXO - SYNCHRONIZER, ECG/RESPIRATOR, RADIOGRAPHIC

892.5650 MANUAL RADIONUCLIDE APPLICATOR SYSTEM

IWG - SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL

GENERAL AND PLASTIC SURGERY PANEL (878)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

878.4200 INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES

KGZ - ACCESSORIES, CATHETER

GCE - ADAPTOR, CATHETER

FGY - CANNULA, INJECTION

GBA - CATHETER, BALLOON TYPE

GBZ - CATHETER, CHOLANGIOGRAPHY

GBQ - CATHETER, CONTINUOUS IRRIGATION

GBY - CATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY

JCY - CATHETER, INFUSION

GBX - CATHETER, IRRIGATION

GBP - CATHETER, MULTIPLE LUMEN

GBO - CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

GBN - CATHETER, PEDIATRIC, GENERAL & PLASTIC SURGERY

GBW - CATHETER, PERITONEAL

GBS - CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

GCD - CONNECTOR, CATHETER

GCC - DILATOR, CATHETER

GCB - NEEDLE, CATHETER

878.4320 REMOVABLE SKIN CLIP

FZQ - CLIP, REMOVABLE (SKIN)

878.4460 SURGEON'S GLOVES

KGO - SURGEON'S GLOVES

878.4680 NONPOWERED, SINGLE PATIENT, PORTABLE SUCTION APPARATUS

GCY - APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

878.4760 REMOVABLE SKIN STAPLE

GDT - STAPLE, REMOVABLE (SKIN)

GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED)

Section Regulation Name

No. Product Code - Device Name

************ ************************************************************************************

878.4820 AC-POWERED, BATTERY-POWERED, AND PNEUMATICALLY POWERED SURGICAL INSTRUMENT MOTOR

GFG - BIT, SURGICAL

GFA - BLADE, SAW, GENERAL & PLASTIC SURGERY

DWH - BLADE, SAW, SURGICAL, CARDIOVASCULAR

BRZ - BOARD, ARM (WITH COVER)

GFE - BRUSH, DERMABRASION

GFF - BUR, SURGICAL, GENERAL & PLASTIC SURGERY

KDG - CHISEL (OSTEOTOME)

GFD - DERMATOME

GFC - DRIVER, SURGICAL, PIN

GFB - HEAD, SURGICAL, HAMMER

GEY - MOTOR, SURGICAL INSTRUMENT, AC-POWERED

GET - MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

DWI - SAW, ELECTRICALLY POWERED

KFK - SAW, PNEUMATICALLY POWERED

HAB - SAW, POWERED, AND ACCESSORIES

878.4960 AIR OR AC-POWERED OPERATING TABLE AND AIR OR AC-POWERED OPERATING CHAIR & ACCESSORIES

GBB - CHAIR, SURGICAL, AC-POWERED

FQO - TABLE, OPERATING-ROOM, AC-POWERED

GDC - TABLE, OPERATING-ROOM, ELECTRICAL

FWW - TABLE, OPERATING-ROOM, PNEUMATIC

JEA - TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

880.5090 LIQUID BANDAGE

KMF - BANDAGE, LIQUID

TABLE 2

CLASS II MEDICAL DEVICES INCLUDED

IN SCOPE OF PRODUCT COVERAGE

AT BEGINNING OF TRANSITION PERIOD

U.S. to develop guidance documents identifying U.S. requirements and EC to identify standards needed to meet EC requirements

RA 892.1000MAGNETIC RESONANCE DIAGNOSTIC DEVICE

MOS - COIL, MAGNETIC RESONANCE, SPECIALTY

LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC

Diagnostic Ultrasound:

RA 892.1540NONFETAL ULTRASONIC MONITOR

JAF - MONITOR, ULTRASONIC, NONFETAL

RA 892.1550ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

IYN - SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

RA 892.1560ULTRASONIC PULSED ECHO IMAGING SYSTEM

IYO - SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

RA 892.1570DIAGNOSTIC ULTRASONIC TRANSDUCER

ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Diagnostic X-Ray Imaging Devices (except mammographic x-ray systems):

RA 892.1600ANGIOGRAPHIC X-RAY SYSTEM

IZI - SYSTEM, X-RAY, ANGIOGRAPHIC

RA 892.1650IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

MQB - SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

RA 892.1680STATIONARY X-RAY SYSTEM

KPR - SYSTEM, X-RAY, STATIONARY

RA 892.1720MOBILE X-RAY SYSTEM

IZL - SYSTEM, X-RAY, MOBILE

RA 892.1740TOMOGRAPHIC X-RAY SYSTEM

IZF - SYSTEM, X-RAY, TOMOGRAPHIC

RA 892.1750COMPUTED TOMOGRAPHY X-RAY SYSTEM

JAK - SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

ECG-Related Devices:

CV 870.2340ELECTROCARDIOGRAPH

DPS - ELECTROCARDIOGRAPH

MLC - MONITOR, ST SEGMENT

CV 870.2350ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR

DRW - ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH

CV 870.2360ELECTROCARDIOGRAPH ELECTRODE

DRX - ELECTRODE, ELECTROCARDIOGRAPH

CV 870.2370ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER

KRC - TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC

NE 882.1400ELECTROENCEPHALOGRAPH

GWQ - ELECTROENCEPHALOGRAPH

HO 880.5725INFUSION PUMP (external only)

MRZ - ACCESSORIES, PUMP, INFUSION

FRN - PUMP, INFUSION

LZF - PUMP, INFUSION, ANALYTICAL SAMPLING

MEB - PUMP, INFUSION, ELASTOMERIC

LZH - PUMP, INFUSION, ENTERAL

MHD - PUMP, INFUSION, GALLSTONE DISSOLUTION

LZG - PUMP, INFUSION, INSULIN

MEA - PUMP, INFUSION, PCA

Ophthalmic Instruments:

OP 886.1570OPHTHALMOSCOPE

HLI - OPHTHALMOSCOPE, AC-POWERED

HLJ - OPHTHALMOSCOPE, BATTERY-POWERED

OP 886.1780RETINOSCOPE

HKL - RETINOSCOPE, AC-POWERED

OP 886.1850AC-POWERED SLIT-LAMP BIOMICROSCOPE

HJO - BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

OP 886.4150VITREOUS ASPIRATION AND CUTTING INSTRUMENT

MMC - DILATOR, EXPANSIVE IRIS (ACCESSORY)

HQE - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

HKP - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED

MLZ - VITRECTOMY, INSTRUMENT CUTTER

OP 886.4670PHACOFRAGMENTATION SYSTEM

HQC - UNIT, PHACOFRAGMENTATION

SU 878.4580SURGICAL LAMP

HBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

FTF - ILLUMINATOR, NON-REMOTE

FTG - ILLUMINATOR, REMOTE

HJE - LAMP, FLUORESCEIN, AC-POWERED

FQP - LAMP, OPERATING-ROOM

FTD - LAMP, SURGICAL

GBC - LAMP, SURGICAL, INCANDESCENT

FTA - LIGHT, SURGICAL, ACCESSORIES

FSZ - LIGHT, SURGICAL, CARRIER

FSY - LIGHT, SURGICAL, CEILING MOUNTED

FSX - LIGHT, SURGICAL, CONNECTOR

FSW - LIGHT, SURGICAL, ENDOSCOPIC

FST - LIGHT, SURGICAL, FIBEROPTIC

FSS - LIGHT, SURGICAL, FLOOR STANDING

FSQ - LIGHT, SURGICAL, INSTRUMENT

NE 882.5890TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF

GZJ - STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Noninvasive Blood Pressure Measurement Devices:

CV 870.1120BLOOD PRESSURE CUFF

DXQ - CUFF, BLOOD-PRESSURE

CV 870.1130NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-oscillometric)

DXN - SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

HO 880.6880STEAM STERILIZER (greater than 2 cubic feet)

FLE - STERILIZER, STEAM

Clinical Thermometers:

HO 880.2910CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)

FLL - THERMOMETER, ELECTRONIC, CLINICAL

AN 868.5630NEBULIZER

CAF - NEBULIZER (DIRECT PATIENT INTERFACE)

AN 868.5925POWERED EMERGENCY VENTILATOR

Hypodermic Needles and Syringes (except anti-stick and self-destruct):

HO 880.5570HYPODERMIC SINGLE LUMEN NEEDLE

MMK - CONTAINER, SHARPES

FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN

MHC - PORT, INTRAOSSEOUS, IMPLANTED

HO 880.5860PISTON SYRINGE

FMF - SYRINGE, PISTON

OR 888.3020INTRAMEDULLARY FIXATION ROD

HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

External Fixators (except devices with no external components):

OR 888.3030SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES & ACCESSORIES

KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

OR 888.3040SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER

JEC - COMPONENT, TRACTION, INVASIVE

HTY - PIN, FIXATION, SMOOTH

JDW - PIN, FIXATION, THREADED

Selected Dental Materials:

DE 872.3060GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE

EJT - ALLOY, GOLD BASED, FOR CLINICAL USE

EJS - ALLOY, PRECIOUS METAL, FOR CLINICAL USE

DE 872.3200RESIN TOOTH BONDING AGENT

KLE - AGENT, TOOTH BONDING, RESIN

DE 872.3275DENTAL CEMENT

EMA - CEMENT, DENTAL

EMB - ZINC OXIDE EUGENOL

DE 872.3660IMPRESSION MATERIAL

ELW - MATERIAL, IMPRESSION

DE 872.3690TOOTH SHADE RESIN MATERIAL

EBF - MATERIAL, TOOTH SHADE, RESIN

DE 872.3710BASE METAL ALLOY

EJH - METAL, BASE

Latex Condoms:

OB 884.5300CONDOM

HIS - CONDOM

TABLE 3

MEDICAL DEVICES FOR POSSIBLE INCLUSION

IN SCOPE OF PRODUCT COVERAGE

DURING OPERATIONAL PERIOD

Anesthesiology Panel

Cardiovascular Panel

Dental Panel

Ear/Nose/Throat Panel

Gastroenterology/Urology Panel

General Hospital Panel

Neurology Panel

Obstetrics/Gynecology Panel

Orthopedic Panel

Physical Medicine Panel

Radiology Panel

General/Plastic Surgery Panel

(1) It is understood that the date of entry into force will not occur prior to June 1, 1998 unless the Parties decide otherwise.