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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 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…

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

04 Aug 2022, Erik Vollebregt

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 that day. I will discuss new and amended headings and subjects in the Blue Guide 2022 compared to the 2016 version in a […]

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Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

20 Jun 2022, We live in interesting times for medical devices in the Union – some have said we are headed for a cliff edge at the end of the grace period. I would personally…

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MDCG guidance as pseudo-legislation

05 Jun 2022, The MDR has been applicable for some time and the IVDR just became applicable. The MDCG has, since both regulations entered into force, issued more guidance documents for the MDR and the…

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Happy IVDR day!

26 May 2022, Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work. And of course I…

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More on placing on the market

18 Feb 2022, After my blog about guidance document MDCG 2021-27 in which I argued why in my view it defines placing on the market wrongly by requiring transfer of a property right as a…

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MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

29 Dec 2021, Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them…