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 […]