Category - IVDR

medicaldeviceslegal

International reliance

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 […]

medicaldeviceslegal

Happy 2025 – more churn for MDR and IVDR!

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 […]

medicaldeviceslegal

Can we fix / improve the MDR and the IVDR?

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 […]

medicaldeviceslegal

MDR and IVDR amendment has entered into force now

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 […]

medicaldeviceslegal

But weren’t they supposed to vote on it on the 14th?

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 […]

medicaldeviceslegal

But weren’t they supposed to vote on it on the 14th?

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 […]

medicaldeviceslegal

MDR and IVDR outlook for 2023

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 […]

medicaldeviceslegal

Focus on the authorised representative

Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so much about the ‘how’, resulting in a guidance that, in typical MDCG fashion, repeats a lot of the law back at you without […]