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The MDR proposal for extension – “Can the maker repair what he makes?”

15 Jan 2023, Erik Vollebregt

On 6 January 2023 it finally happened: the moment that many had been waiting for – the MDR extension proposal finally dropped (see here for Commission provided background). It did not turn out to be what I expected in all respects. First, it contained also an amendment to the IVDR: a removal of the sell-off […]

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Trilogue MDR/IVDR will probably not complete this year

30 Nov 2015, Erik Vollebregt

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Update on MDR/IVDR trilogue

09 Nov 2015, Erik Vollebregt 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

06 Nov 2015, Erik Vollebregt 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

26 Oct 2015, Erik Vollebregt 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

21 Jun 2015, Erik Vollebregt 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

16 Jun 2015, Erik Vollebregt 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

16 Jun 2015, Erik Vollebregt 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

15 Jun 2015, Erik Vollebregt 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…