Category - IVDR

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 […]

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

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 […]

medicaldeviceslegal

MDR date of application next month – and the book

Finally! Another post on this blog. You would think that I would write a lot on a blog like this just before the date of application of the MDR next month, right? Well, I did – just not on the blog but I was working hard to finish my book on the MDR and IVDR […]

medicaldeviceslegal

Finally remote initial audits, or not (yet)?

When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment on 11 January, there was much rejoicing in the medical devices community. Yay! It looked like […]

medicaldeviceslegal

Outlook for 2021 – and happy new year!

Something new for the end of the year: a new year’s vlog with my rough 2021 outlook. This outlook is far from complete and not comprehensive at all, and it leaves out many other important things. Make sure to stay informed (or as Kant the philosopher said: dare to be wise)! If you like this […]