NIST GCR 01-815
A Guide to the EU Medical Device Directive

2) They are intended for use for storing or channeling blood or other body liquids or for storing organs, parts of organs or body tissues are in Class IIa.

Examples:

• Devices intended to channel blood (e.g., in transfusion, extracorporeal circulation).
• Devices intended for temporary storage and transport of organs for transplantation.
• Devices intended for long term storage of biological substances and tissues, such as: corneas, sperm, human embryos, etc.

In all other cases, they are in Class I.

Examples:

• Devices that provide a simple channeling function, with gravity providing the force to transport the liquid, e.g., administration sets for infusion.
• Devices intended to be used for a temporary containment or storage function such as cups and spoons specifically intended for administering medicines.
• Syringes without needles.

Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body are in Class IIb

Examples:

• Devices intended to remove undesirable substances from the blood by exchange of solutes such as hemodyalizers.
• Devices intended to separate cells by physical means, e.g., gradient medium for sperm separation.
• Haemodialysis concentrates.

If these non-invasive devices are used in a treatment that consists of filtration, centrifugation or in exchanges of gas or heat, they are in Class IIa.

Examples:

• Particulate filtration of blood in an extracorporeal circulation system. These are used to remove particles and emboli from the blood.
• Centrifugation of blood to prepare it for transfusion or autotransfusion.
• Removal of carbon dioxide from the blood and/or adding oxygen.
• Warming or cooling the blood in an extracorporeal system.

Rule 4

All non-invasive devices which come into contact with injured skin are in Class I if they are intended to be used as a mechanical barrier, for compression, or for absorption of exudates.

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