Category - IVDR

medicaldeviceslegal

Brexit is a fact – now deal with it

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

medicaldeviceslegal

A not so happy MDR and IVDR Christmas Carol

Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview. As the year draws to an end, the date of application of the MDR is very close now and I see more and more things happen that everybody could see coming for a long time, I would like […]

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

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 […]

medicaldeviceslegal

PRRC guidance under MDR and IVDR published

The MDCG has just published its guidance on the PRRC, MDCG 2019-7 “Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)”. The guidance is largely unsurprising but I would like to highlight some points that are relevant to companies […]

medicaldeviceslegal

Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large […]