Other medical devices documents

This section will be regularly updated with topical documents.

Medical Devices DirectiveThe Medical Devices Directive.
In Vitro Diagnostics Directive The In Vitro Diagnostics Directive.
Draft EC Decision on Animal Derived Material This document is the draft decision that has been issued by the European Commission that will effect all CE marking for devices that incorporate animal derived material.
EC Decision CTS This is the European Commission Decision on the Common Technical Specification (CTS) relevant to List A In Vitro Diagnostics.
RTTE Paper This is a question and answer style paper that provides some guidance on the requirements the RTTE Directive relevant to medical devices
EU Medical Expert Group Report on the Functioning of the Medical Devices Directive 5 June 2002

Documents correct as of 12/11/04, please check the European Commission's Website for the most up to date versions.

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