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MDR date of application next month – and the book

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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Finally remote initial audits, or not (yet)?

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!

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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