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 […]

medicaldeviceslegal

The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required

Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a very international business? Indeed – so the ability for companies working with the MDR and IVDR to transfer personal data internationally for all […]

medicaldeviceslegal

Standardisation request for MDR and IVDR refused – now what?

A new blog post, a new step in the soap that is the non-transitional period of the MDR and the IVDR. I have jokingly paraphrased the absurdist painter Magritte by saying “céci n’est pas une période de transition”. I’m contemplating starting a T-shirts business with memes for the MDR and IVDR, with that meme and […]

medicaldeviceslegal

The urgency with IVDs and the IVDR

Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry? The hurry has everything to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]

medicaldeviceslegal

The urgency with IVDs and the IVDR

Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry? The hurry has everything to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]