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MedTech Forum 2012: “S is for scrutiny, which we’re not sure about”

In CE Mark, CE Medical, Medical CE, PMA, Scrutiny Process on October 16, 2012 at 12:50 pm

Erik has the distinct honor of being my first “Reblog”. In this blog posting he has done an exceptional job of capturing the political issues behind the proposed EU Medical Device Regulation. Erik is as close to the source as someone outside the Commission can be, and his knowledge is evident throughout his frequent postings–which I read and re-read each week.

His firm is offering a free on-line seminar related to the new regulations on November 14th. Make sure that you register with Marjon ahead of time.

Click on this link for information about the seminar.

medicaldeviceslegal

“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday to Friday. This conference is an ideal moment to take stock of the EU medtech industry. No wonder that everyone was there to discuss the newly proposed medical devices and in vitro diagnostics regulations. If you want a summary report of the plenary sessions, a good picture emerges from the tweets on the hashtag #mtf2012 by @meddevlegal (that’s me), @clinicamedtech, @emdt_editor and @maxwellmedtech between 10 and 12 October 2012. The picture that emerges is that the industry welcomes the new rules in general, thinks some details must be clarified and is worried about what the proposed scrutiny procedure will look like after it has gone through the legislative procedure and the Parliament has had its way with the…

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