Article

Welcome to 2020 – year of the proof of the MDR pudding

13 Jan 2020, Erik Vollebregt

Welcome to 2020 – happy new year everyone. I don’t care if your conventions do not allow me to wish you best wishes after a certain date anymore. I wish you a happy 2020 because I genuinely hope you will have it. If you are a reader of this blog and you have a happy […]

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A not so happy MDR and IVDR Christmas Carol

25 Dec 2019, Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview. As the year draws to an end, the date of application of the MDR is…

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More on the PRRC

12 Dec 2019, I have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year. With more experience with the subject in the mean time and everybody working to understand…

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The Commission and the Council on the MDR state of affairs

10 Dec 2019, The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see…

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Corrigendum 2 and the (potential) consequences for class I devices

09 Dec 2019, Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains…

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Eudamed delayed, but MDR not delayed – now what?

05 Dec 2019, You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go…

Article

Eudamed delayed, but MDR not delayed – now what?

19 Nov 2019, Erik Vollebregt

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]

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Counting down to the MDR date of application, and the legal stuff to get right before May 2020

29 Oct 2019, Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices…

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Seminar MDR & IVDR Implementation Countdown – slides

02 Oct 2019, Axon Admin 191002-Erik Vollebregt-MDR Countdown 191002-Paul van Geffen- Last elements before implementation 191002-Sue Spencer – IVDR Executive summary 191002-Ronald Boumans- Latest on Eudamed