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 gave a presentation on current and future developments in UDI at the RAPS 2014 conference in Austin last week, sitting on a panel on global developments in UDI with presentations on developments also in the US and China. This will be a short post on the subject of UDI, because most of the information […]
It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going on in the medical devices regulatory developments field. Yes, market parties have been working on their input for the consultation about the Green Paper […]
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 […]
After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of the last meeting in Nice, France of 19-21 March gives us a peek into what is happening. Standalone software The new work items […]
I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was a very good conference with some of the best EU experts sharing their knowledge. There were also some easter eggs of information. The […]
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 […]