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

MDCG guidance as pseudo-legislation

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 IVDR in a few years than were ever issued for the old directives in several decades. Sounds like progress! High fives all around […]

medicaldeviceslegal

Happy IVDR day!

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 have been working hard on the second edition of the big book, the Enriched MDR and IVDR, which is nearing completion and will […]

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

IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house produced devices) due to my enthusiasm to get the news out quickly. In the mean time I have fixed these […]

medicaldeviceslegal

IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5 (5) IVDR (in-house produced devices) due to my enthusiasm to get the news out quickly. In the mean time I have fixed these […]