Article

MDR and IVDR outlook for 2023

01 Jan 2023, What to expect for the MDR and IVDR in 2023? Predictions are very hard, especially if they are about the future. That’s a paraphrase of a very solid Danish nugget of wisdom…

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The EPSCO meeting and beyond: further steps for the MDR and IVDR implementation regime changes

11 Dec 2022, The 9 December EPSCO meeting in which the Commission was going to make its big reveal to fix the MDR came and went and left many people with a lot of conflicting…

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Focus on the authorised representative

06 Nov 2022, Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so…

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The 2nd edition of The Enriched MDR and IVDR is available now

27 Oct 2022, It took a while, but here it is: the 2nd edition of The Enriched MDR and IVDR, updated with developments from early april 2021 to early September 2022. The first edition of…

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The New Product Liability Directive(s) proposals and medical devices / IVDs

09 Oct 2022, On 28 September the Commission adopted two related proposals for EU regulation of no-fault liability for defective products. One proposal updates the ‘old’ Product Liability Directive (PLD) from 1985 to make it…

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Verelendung is a process, people!

12 Sep 2022, Over the summer holidays I (and perhaps some other people too) were in burning anticipation about announced measures to be adopted to deal with the MDR slowly moving to a big crunch…

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The Blue Guide 2022 update – new elements regarding applicability of EU law on products

15 Aug 2022, As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post…

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The Blue Guide 2022 update – new elements regarding applicability of EU law on products

07 Aug 2022, Erik Vollebregt

As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post follows up in detail on the changes in Chapter 2. Chapter 2 of the Blue Guide explains when EU law on products applies, […]

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The new Blue Guide 2022 – not much new for devices and IVDs, but certainly more confusion

05 Aug 2022, In short After approximately six years after the previous (2016) version of the Blue Guide the 2022 version finally ‘dropped’ on 29 June 2022 in the Official Journal edition C edition of…