Category - transparency

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

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 the blog, with an overview of the developments discussed in it. Can’t ask what can’t be offered 2014 was the year in which […]

medicaldeviceslegal

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 Glenis Willmott, of the S&D group in the European Parliament, who is certainly familiar with health issues as she has served for example as […]

medicaldeviceslegal

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 have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]