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IVDR, IVDs and mass extinction

13 Sep 2017, Erik Vollebregt More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD…

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Supply chain and economic operator regulation under the MDR and IVDR

12 Sep 2017, Erik Vollebregt One of the interesting features of the new MDR and IVDR is the new chapter on economic operators (chapter II), which implements a completely new (to the medical devices industry at least)…

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San Jose CA workshop: Everything You Always Wanted to Know about the EU Medical Devices Regulation, but Were Afraid to Ask

10 Sep 2017, Erik Vollebregt If you have questions about what the MDR will mean for your company and happen to be in San Jose in California on 25 September, consider attending the evening workshop that Factory…

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MDR and IVDR transitioning – where are you in your process?

03 Aug 2017, Erik Vollebregt

I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where everyone will be by the time the transitional period of the MDR ends and then when the IVDR transitional period ends. This post […]

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MDR and IVDR transitioning – where are you in your process?

03 Aug 2017, Erik Vollebregt I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where…

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An unsurprising case of software qualification

31 Jul 2017, Erik Vollebregt First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and…

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Netherlands to adopt medical devices anti-corruption legislation

05 Jun 2017, Erik Vollebregt As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of…

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Presentations MDR Implementation Seminar

10 May 2017, Erik Vollebregt With the definite text published less than a week ago, we welcomed over 150 industry representatives interested in the new Medical Devices Regulation. Erik Vollebregt kicked off the seminar with his presentation…

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Final MDR and IVDR texts published

05 May 2017, Erik Vollebregt As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU)…