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The new EU AI regulation proposal, medical devices and IVDs

05 May 2021, Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I,…

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MDR date of application next month – and the book

12 Apr 2021, Finally! Another post on this blog. You would think that I would write a lot on a blog like this just before the date of application of the MDR next month, right?…

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MDR date of application next month – and the book

11 Apr 2021, Erik Vollebregt

Finally! Another post on this blog. You would think that I would write a lot on a blog like this just before the date of application of the MDR next month, right? Well, I did – just not on the blog but I was working hard to finish my book on the MDR and IVDR […]

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Finally remote initial audits, or not (yet)?

24 Jan 2021, When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed…

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Outlook for 2021 – and happy new year!

29 Dec 2020, Something new for the end of the year: a new year’s vlog with my rough 2021 outlook. This outlook is far from complete and not comprehensive at all, and it leaves out…

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Outlook for 2021 – and happy new year!

29 Dec 2020, Erik Vollebregt

Something new for the end of the year: a new year’s vlog with my rough 2021 outlook. This outlook is far from complete and not comprehensive at all, and it leaves out many other important things. Make sure to stay informed (or as Kant the philosopher said: dare to be wise)! If you like this […]

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The Brexit ‘deal’ – what’s (not) in it for the medical devices industry?

28 Dec 2020, Spoiler: at the moment basically nothing except more paperwork and trade barriers. It’s still a hard Brexit with a little sugar on top, essentially. Or, if you are a more glass half…

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The Brexit ‘deal’ – what’s (not) in it for the medical devices industry?

28 Dec 2020, Erik Vollebregt

Spoiler: at the moment basically nothing except more paperwork and trade barriers. It’s still a hard Brexit with a little sugar on top, essentially. Or, if you are a more glass half full kind of person: at least not all the way back to WTO rules but a just one step above that. After a […]

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The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required

23 Jul 2020, Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a…