Category - EDMA


More white smoke – trilogue for MDR and IVDR in progress

White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the MDD and IVDR on 5 October, endorsing its negotiating position on the medical devices and in vitro diagnostic medical devices draft Regulations. The […]


Netherlands medical devices compliance update

Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all other member states, the Netherlands had to play their part in executing the Joint Immediate Action Plan. Also, they have some ideas of […]