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….


Netherlands compliance update

On 13 January I presented the yearly complaince update for the Netherlands to the Medtech Europe Compliance Network in Brussels. Since the presentation is no secret know-how, I thought I’d share it on…


More movement – new rapporteur for MDR, same for IVDR

Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP…


What will the Intermune and Abbvie cases mean for the medical devices industry?

I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that…


Euro update and Don't Lose The SME

While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to…

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