medicaldeviceslegal

Final MDR and IVDR texts published

As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU) 2017/745) and the IVDR (finally numbered as Regulation (EU) 2017/746), downloadable in any language that you could possibly like. I wish you a pleasant […]

medicaldeviceslegal

MDR and IVDR to be published this Friday

Mark 5 May 2017 in your calendar – this date will be a landmark for EU medical devices law because the MDR and IVDR will be published in the EU Official Journal. This means that the MDR and IVDR will enter into force on the twentieth day following that of their publication and from that date […]

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 […]

medicaldeviceslegal

Festive alert! Change is on its way.

Change is on its way – medical devices law will not be the same again as of next year. Panic soccer The authorities are not your friend anymore. Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot. If you have not implemented the new clinical evaluation MEDDEV fully by […]

medicaldeviceslegal

Privacy by design and data portability

I’ve often warned medical devices companies that they need to start looking at privacy by design obligations under the General Data Protection Regulation, the GDPR. Engineers at a company where I gave an in-company presentation earlier this year were seriously unhappy that privacy by design obligations can affect both hard and software and that the […]