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 […]

medicaldeviceslegal

Proposal to manage IVDR

It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow little, neglected sister of the MDR implementation with greatly insufficient notified body capacity becoming available, and crucial elements of regulatory infrastructure (like 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 […]