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 […]

medicaldeviceslegal

MDR date of application move: politically a done deal now

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]