Monday, March 15, 2010 12:48 AM
The (New) Medical Device Directive – What’s Changing?
By Dr. Evangeline Loh and Sage Farrar
The new Medical Device Directive (MDD) amended by Directive 2007/47/EC and implemented 21 March 2010, levies the first significant modifications to the MDD since 1993. This article provides a brief overview of the major changes that the new MDD imposes, and also guidelines to the revised requirements regarding Clinical Data.
After 21 March 2010, medical devices placed on the European market or put into service, must conform to the (new) requirements of the MDD, as modified by 2007/47/EC. These requirements are applicable to each individual device. The terms “placing on the market” and “putting into service” are defined in the directives. Further, products already lawfully on the market or put into service prior to 21 March 2010 can continue to be marketed. Since manufacturers are required and presumed more...
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Friday, July 30, 2010 by
With regards Clinical Investigations: The MEDDEV mentioned further refers to the Harmonised ISO standards (14155-1&2) which are now at revision 2009, replacing the previons version. Compliance with an appropriate harmonised European Standard gives a presumption of conformity with the essential requirements to which the standard relates.
E.Parry
Monday, April 26, 2010 by
Traceability requirements and retention of records remain in place (with tighter controls for some devices) and is always accessible to the public under request by contacting the CE Mark owner directly.
Thursday, April 15, 2010 by
The modifications by Directive 2007/47/EC does not alter the definition of "Manufacturer" which is the entity identified on the labelling and who also possesses the CE marking. In the future, there will be a European database, Eudamed, which will be operational but this will not be publically accessible: http://ec.europa.eu/idabc/en/document/2256/5637. So there will not be a repository of medical devices which have CE marking which will be publically accessible.
- Ed. (on behalf of the authors)
Sunday, March 21, 2010 by
Will this new directive require that the real manufacturer is mentionned , as opposed to the CE Mark owner and
would there be a positive list of all products CE Marked accessible to public ?
Jean-Claude Mornod,
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