Category - Recast

medicaldeviceslegal

Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December. That is, for this Presidency (the Luxemburg one). If the  Commission, Parliament and Commission do not manage to reach consensus on everything, the […]

medicaldeviceslegal

Update! White paper on MDR / IVDR updated

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 […]

medicaldeviceslegal

More white smoke – trilogue for MDR and IVDR in progress

White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the MDD and IVDR on 5 October, endorsing its negotiating position on the medical devices and in vitro diagnostic medical devices draft Regulations. The […]

medicaldeviceslegal

The Council’s IVD regulation proposal for the general approach

As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will try to not repeat what I have blogged about yesterday given the large amounts of overlap between the two regulation proposals. Where things […]

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 […]