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….


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….


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…


White smoke: we have a general approach for the medical devices and IVDs regulations

Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday. The press release also conveniently bundles…

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