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National MDR and IVDR implementation news – Netherlands implementation decree consultation

12 May 2019, Erik Vollebregt

While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the gridlocked Brussels MDR and IVDR implementation process as a result of structural under-resourcing of medical devices oversight) some member states are really on […]

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IVDR, in-house developed tests and the state of MDR/IVDR implementation

12 May 2019, Erik Vollebregt In several posts on this blog I have discussed the severe impact that the IVDR will have on the IVD industry selling in the EU (just click on IVDR in the tag…

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This was not the Corrigendum you were looking for

28 Mar 2019, Erik Vollebregt So, we have had yet another couple of weeks with many things happening, so you may enjoy the two core slides from a recent presentation of mine at the NEN MDR conference…

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Cannabis derived food products – what’s the current state of play?

11 Mar 2019, Karin Verzijden Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products…

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First notified body EU MDR designated!

21 Jan 2019, Erik Vollebregt BSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation –…

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MDR and IVDR in 2019: up or out, sink or swim

07 Jan 2019, Erik Vollebregt Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of…

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Ceci n’est pas une période de transition and first reaction to the Implant Files

02 Dec 2018, Erik Vollebregt

As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear:  the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]

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Ceci n’est pas une période de transition and first reaction to the Implant Files

02 Dec 2018, Erik Vollebregt As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become…

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The Netherlands ∙ Proposed Solutions to Tackle Expensive Medicines in The Netherlands: A Critical Review

27 Aug 2018, Erik Vollebregt If you have an interest in Life Sciences, I am glad to draw your attention to my Report in the latest edition of the European Pharmaceutical Law Review (EPLR). As many of…