No Valid excuses For Manufacturers To Delay IVD Regulation Applications

Two leading notified body experts, BSI’s Graeme Tunbridge, and TÜV SÜD’s Andreas Stange, in addition to consultant Gert Bos, once head of BSI notified body medtech services, joined Medtech Insight’s Amanda Maxwell to examine what impact the IVDR amending regulation, published some 18 months ago, has had on manufacturer applications to notified bodies. They revealed that the hyper around backlogs at notified bodies is exaggerated and not an excuse for inaction. The content of this podcast is reflected in this article and one due to be published in Medtech Insight on 6 July.