Update! White paper on MDR / IVDR updated

13_img0_BSI Core LogoIn March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure. It was well received and as the legislative procedure for the regulations progressed there has been an increasing demand for update of the white paper.

Updated white paper

That update is now available and you can download it from here. The updated white paper reflects the situation as per the start of the trilogue beginning of October this year (5 October EPSCO meeting), so it takes the last publicly available Council proposed text into account. Like the previous version we hope that it will be of use for everyone!


Navigate through our knowledgebase

Related articles

Article

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…

Read more

Article

Corrigendum 2 and the (potential) consequences for class I devices

Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains…

Read more

Article

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…

Read more