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

Rule 17

All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III, except where such devices are intended to come into contact with only intact skin.

Examples:

• Biological heart valves, porcine xenograft dressings, catgut sutures, implants and dressings made from collagen.

Rule 18

By derogation from other rules, blood bags are in Class IIb.

Examples:

• Blood bags (including those containing or coated with an anticoagulant). Where blood bags have a function greater than for storing purposes and include systems for preservation other than anti-coagulants then other rules (e.g., rule 13) may apply.

See Flow Diagrams* of this report.

III. Conformity Assessment Routes

Class I
Class I devices must follow the procedures specified in Annex VII of the Medical Device Directive. In addition, the manufacturer must draw up a Declaration of Conformity (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 26). The involvement of a Notified Body (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 20) is not needed and the manufacturer can self declare the product to be in compliance with the essential requirements of the Medical Device Directive.

Class I (Sterile or Measuring) and Class IIa
The manufacturer may choose one of the following conformity assessment routes to demonstrate conformity of the product to the Medical Device Directive:

Annex II,
Annex VII and Annex IV,
Annex VII and Annex V, or
Annex VII and Annex VI.

Requires the intervention of a Notified Body. Note: In lieu of these routes, a manufacturer may follow the conformity routes for Class IIb devices, although the classification of the device would remain the same - Class I or Class IIa

* PDF file format requires the FREE ADOBE ACROBAT READER Software.

If you are unable to use the ADOBE ACROBAT READER Software and require a copy of a PDF document, please request a copy to be sent to you from maureen.breitenberg@nist.gov

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