In 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!