medicaldeviceslegal

IVDR, IVDs and mass extinction

More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD regulation was truly outstanding. I do not often see such a good program on EU IVD regulation in one place – if you […]

medicaldeviceslegal

An unsurprising case of software qualification

First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and the IVDR. The summer is a bit more quiet so you can expect more content again. Intermezzo on software under MDR and GDPR […]

medicaldeviceslegal

Netherlands to adopt medical devices anti-corruption legislation

As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of industry/HCP interactions (the “Wet van 17 mei 2017 tot wijziging van wetgeving op het terrein van de zorg in verband met het invoeren […]

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) […]