Manufacturers need to apply now for certification under the IVD Regulation, or further bottlenecks could form later down the line when deadlines approach for each of the risk classes.
Nor is there any excuse why they should delay further. There are no significant backlogs at EU notified bodies for the assessment of these products, contrary to recent reports. And...
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...