Category - Clinical evaluation

medicaldeviceslegal

MDR/IVDR Implementation: the transition period halfway point

If you are still free this Wednesday afternoon and somehow involved on the medical devices industry in the EU, our seminar that afternoon in Amsterdam is for you as it discusses where we are with the implementation of the MDR and IVDR. We still have a few seats available, so this will be time well […]

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

Compromise texts for EU Council EPSCO meeting public

The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start the trilogue have been published for the medical devices regulation proposal and for the IVD regulation proposal. Only part of the picture Unfortunately […]

medicaldeviceslegal

The devices have landed – and some promotion

So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR. I have also heard Commission officials tasked with medical devices at DG SANCO say they are in transition now. It also became clear […]