Category - GDPR

medicaldeviceslegal

Happy New Medical Devices Year!

Happy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely. May your management be convinced that making and selling medical devices is actually core business of the company and dedicate sufficient resources to your transition project. Halfway point of MDR transition 2018 is the year in which we will […]

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

Medical devices M&A – data protection

Lately I have been doing a lot of work in medical devices M&A projects, some very big, some quite small and some in between. Everybody seems to be merging with everybody else these days as the bigger companies divest branches to reposition and smaller companies put themselves up for sale. These projects are invariably highly […]

medicaldeviceslegal

End of year bonanza

Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]

medicaldeviceslegal

Data protection developments: privacy by design – literally

If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]