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 […]