Medical devices legal and regulatory blog
I have done more traveling than I probably should have in January and February between the US, the Middle East and various places in Europe. One of the constant themes was the place of a regulatory regime in the world and how to calibrate the regulatory system just right in the way that it meets [ ]
Happy new year everyone! I hope you had a good rest over the holidays because 2025 will be interesting. I am planning to revive this blog this year and hope to put new energy in it by making it more periodical with smaller bits of information and shorter analysis. You will still get my unique [ ]
After having contributed to the improvement of medical devices legislation in many ways over the years (most recently by helping the European Parliament to come up with an initiative for targeted amendments to the MDR) it is now my great honour to have been invited as external independent expert to assist the Bundestag (the German [ ]
The MDR and IVDR are now in force for seven (7) years, and they are not in good shape. I think it is safe to say that they did not deliver on their promise of a better, more streamlined and more SME and innovation friendly regulatory system. Deadlines keep being moved, patchwork happens here and [ ]
Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a case about VAT levied on medical devices, rendered on 8 September. Some background: in the Netherlands we like to use taxes as a [ ]
Or in other words that I ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to me: people that say that the MDR or IVDR is ‘new’. In a way of course they are if you look at things [ ]
Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this, the amendment now applies all throughout the Union as referenced in article 1 MDR and IVDR. Union as in not European Union, which [ ]
Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of them that watched the vote on the Parliament s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the [ ]
On 6 January 2023 it finally happened: the moment that many had been waiting for the MDR extension proposal finally dropped (see here for Commission provided background). It did not turn out to be what I expected in all respects. First, it contained also an amendment to the IVDR: a removal of the sell-off [ ]
What to expect for the MDR and IVDR in 2023? Predictions are very hard, especially if they are about the future. That’s a paraphrase of a very solid Danish nugget of wisdom attributed to the physicist and chemist Nils Bohr. But let’s see what we can do based on some basic extrapolation of things currently [ ]