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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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News and Views April 2012


4. Recent Scandal in regards to fraud on breast implants in Europe and its consequences

The fraud on breast implants made it to the public news since so many women in Europe and other parts of the world are affected.  In order to get an overview of the situation you simply may type in at Google or any other search engine on the internet : "PIP scandal"

The discussions and also consequences for the medical devices manufacturer can be found here:

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/119&format=HTML&aged=0&language=EN&guiLanguage=en

and here:

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/96&format=HTML&aged=0&language=EN

The main lesson which should be learned is that the regulation is not able to prevent fraud but the overall consensus among regulators is to increase the possibility to identify fraud with unannounced visits.  These may already be possible with the current regulation (unannounced visits of your notified body) but we may in particular see such solution being implemented with the recast of the directive.  Having said this it becomes obvious that this scandal already is influencing the new regulation to come. 

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