NIST GCR 01-815
A Guide to the EU Medical Device Directive
Examples:
- Wound dressings, such as absorbent pads, island dressings, cotton wool, wound strips and gauze dressings to act as a barrier or to maintain the wound positionally or to absorb exudates from the wound.
Non-invasive devices are in Class IIb if they are intended to be used principally with wounds that have breached the dermis and can only heal by secondary intent.
Examples:
- Non-invasive devices that are principally intended to be used with severe wounds that have substantially and extensively breached the dermis, and where the healing process can only be by secondary intent, such as: dressings for chronic extensive ulcerated wounds; dressings for severe burns having breached the dermis and covering an extensive area; dressings for severe decubitis wounds; and dressings incorporating means of augmenting tissue and providing a temporary skin substitute.
In all other cases, the devices are in Class IIa, including devices principally intended to manage the micro-environment of a wound.
Examples:
- Devices with specific properties intended to assist the healing process by controlling the level of moisture at the wound during the healing process and to generally regulate the environment in terms of humidity and temperature, levels of oxygen and other gases and pH values or by influencing the process by other physical means.
- These devices may specify particular additional healing properties while not being intended for extensive wounds requiring healing by secondary intent.
- Adhesives for topical use.
- Polymer film dressings, hydrogel dressings and non-medicated impregnated gauze dressings.
2. Invasive devices
Rule 5
All invasive devices with respect to body orifices that are not surgically invasive devices and that are not intended for connection to an active medical device are:
1) in Class I if they are intended for transient use;
Examples:
- Handheld mirrors used in dentistry to aid in dental diagnosis and surgery, dental impression materials, tubes used for pumping the stomach, impression tray, enema devices, examination gloves and prostatic balloon dilation catheters.
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