Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an IVDR seminar

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 and IVDR will mean for them, and what they need to do to avoid suffering the consequences of ignoring the call of reality. In the mean time the MDR and IVDR implementation roll-out rolls on and the transition period is [...] « Read the rest of this article on medicaldeviceslegal »