medicaldeviceslegal

More on the PRRC

I have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year. With more experience with the subject in the mean time and everybody working to understand the subject, I thought it was a good idea to revisit the subject. And another good reason was that I had to look […]

medicaldeviceslegal

The Commission and the Council on the MDR state of affairs

The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see the state of affairs with the MDR and IVDR implementation at the moment, and notably as well the delay of Eudamed implementation. The […]

medicaldeviceslegal

Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]