As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear: the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]
You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on the left). A lot of companies in devices still do not seem to get what the enormous change brought about by the MDR […]
I had the pleasure of presenting at the Informa Conference on the Medical Devices Directives and the Revision in Brussels today. An nice conference with a good overview of what is coming our way in terms of EU medical devices regulation 2.0 – or not. Everything to everyone My subject was the Eudamed database under the revision project […]
Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to safeguard the credibility of the EU medical devices vigilance system (which are conveniently summarised in his speech of 9 Febuary 2012): the Dutch […]
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7. It is clear that the EU is upping its game on vigilance with the ongoing criticism on the CE system for medical devices, […]