medicaldeviceslegal

We are looking forward to meet you!

My apologies for the incidental self-promotion. Our practice continues to grow and that means we are always looking for people to staff our firm. We currently have vacancies for a number of lawyers at different levels of seniority. I will therefore tap into the community and hope you can help. So, if you know of any (Dutch law) […]

medicaldeviceslegal

This is it: MDR and IVDR texts now ready for final voting

The fat lady has her lines and is about to sing. After the lengthy legal linguist revision process (remember, these texts have to be consistent in 24 languages) the Council published the text for its first reading for the MDR and IVDR.   First reading only, after such a lengthy process in which we arrived at […]

medicaldeviceslegal

Where would we be without good people?

Nowhere of course – that’s why it’s so important to keep them motivated and retained. My firm is organising a seminar in Amsterdam on 1 March on Motivation and Retention Strategies in the Life Sciences Industry, with a focus on possibilities under employment, corporate and tax law. You are most cordially invited to attend with […]

medicaldeviceslegal

EU Court decides TÜV Rheinland / PIP breast implants case

It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]

medicaldeviceslegal

An MDR and IVDR transition plan

The year is off to a good start, and so should your company be with its MDR and/or IVDR transition plan. Come again? You haven’t started looking at this yet because the MDR and IVDR are not yet final and the transitional period will run to approximately half 2020? Your management is not interested in […]