Industry to Meet as BfArM, MHRA and Leading Notified Bodies Share their Views on the Altered Medical Device Directive MDD (2007/47/EC)

In the wake of alterations to the Medical Device Directive (MDD [2007/47/EC]), industry leaders are to converge in Berlin on 19-20 October 2010 to discuss the implications of these alterations, the expectations of the regulatory and notified bodies, and the impact this will have on the medical device industry.

Originally initiated in 2007, the official amendments, release by the European Union, come into force on 21 March 2010, in an effort bring about a more regulated environment for medical devices in Europe, not only when gaining CE approval but also for safety reporting requirements.

Medical devices giants such as Abbott Medical Optics, GE Healthcare and Siemens are meeting in October at Pharma IQ’s Clinical Evaluations and Investigations for Medical Devices Conference in Berlin to discuss these recent developments and share information on the latest strategies, technology and techniques being employed by leaders of the field to ensure continued compliance.

Gert Bos, head of clinical and regulatory affairs, BSI Healthcare and a speaker at the conference, said: “At this moment we are confronted with a rapidly changing environment, in which the new legal framework calls for a recast of medical device directives as well as IVDs directly following the previous revision in 2007/47/EC. Electronic labelling will see the light and the focus on ongoing compliance is enforced by post market surveillance, vigilance and strengthened serious adverse event reporting in clinical trials. Staying on the ball is more crucial than ever before.”

The effects that the MMD is having on how the European medical device industry operates are profound. Notified bodies and industry leaders will be addressing the key issues, problems and opportunities at the upcoming Clinical Medical Device Conference in Berlin.

For more information about the upcoming Clinical Evaluations and Investigations for Medical Devices Conference visit www.clinicalmedicaldevice.com or phone +44 20 7368 9300.

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