medicaldeviceslegal

EU MDR / IVDR Regulatory Cassandra

Sometimes you have days that you feel like Cassandra. I had a Cassandra moment after moderating the MDR panel at the Advamed MedTech Conference on 25 September. Cassandra was a lady from mythological heritage. She made the Greek god Apollo angry by changing her mind to be his girlfriend after he had granted her the […]

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 […]