Category - MDR

medicaldeviceslegal

Focus on the authorised representative

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 much about the ‘how’, resulting in a guidance that, in typical MDCG fashion, repeats a lot of the law back at you without […]

medicaldeviceslegal

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

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 the book was revised thoroughly, many new clauses in the MDR and IVDR were annotated and obsolete information was removed. New flowcharts and […]

medicaldeviceslegal

Verelendung is a process, people!

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 or other equivalent astrophysical end state event at the end of the grace period. MDCG 2022-14 on Notified body capacity and availability of […]

medicaldeviceslegal

More on placing on the market

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 condition for placing on the market, a lot of discussion started. I even received an email from the European Commission commenting on the […]

medicaldeviceslegal

Happy MDR DoA and Swixit / noTurkxit day!

As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR! The (AI)MDD is no more now, but is it? Three important events happened today that are all relevant to this question: the MDR became applicable, the Swixit […]

medicaldeviceslegal

The Enriched MDR and IVDR – finally available

Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that writing books while having a more than full-time job running a law firm and being a busy lawyer is a bit of a […]

medicaldeviceslegal

The new EU AI regulation proposal, medical devices and IVDs

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, section 17 MDR and Annex I, section 16 IVDR, the Commission proposes new mandatory regulation to supplement the the MDR and the IVDR […]