Recast

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Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December….

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Update! White paper on MDR / IVDR updated

In March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure….

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More white smoke – trilogue for MDR and IVDR in progress

White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the…

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White smoke: we have a general approach for the medical devices and IVDs regulations

Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday. The press release also conveniently bundles…

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More on scrutiny in the general approach proposals for medical devices and IVDs

Upon closer examination of the two texts for the MDR and IVDR it became clear that the scrutiny proposals in both regulations are actually identical (sorry for the earlier confusion). Accordingly, there are…

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The Council’s IVD regulation proposal for the general approach

As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will…

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Compromise texts for EU Council EPSCO meeting public

The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start…

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Towards a general approach for the EU medical devices and IVD regulation proposals?

To get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently. EPSCO council 18/19 June With the Latvian presidency…

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