06/02/2008

An official consolidated text is available; it includes the changes brought by the Directive 2007/47/EEC into both directive 90/385/EEC (active implantable medical devices) and 93/42/EEC (medical devices).

On March 5th 2010, all the changes will have to be implemented.

For some of the changes, guidelines have been asked to the European Commission. ABR will keep you informed of the progress.

Review of the changes:

Addition of the following definition

clinical data can outcome from clinical investigations, studies, published or unpublished reports from a device for which equivalence to the evidence in question can be demonstrated.

In this case the change will have implications on:

• the Technical File (the file describing your product from the raw materials, the process, and all toxicological and clinical investigations), in which it will be introduced the conclusions of the analysis of the outputs of clinical studies of equivalent MD’s.
• the Quality system (procedures, working instructions, …) in which it will be introduced reports of clinical investigations in the design output and study of evidences to demonstrate conformity of MD to Essential Requirements on the basis of the studies of equivalent MD’s.

To be continued