Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD experts.
As guidances for the IVDR and Medical Device Regulation (MDR) have trickled out, some experts said they are concerned that the guidances always contain the recommendations they presumed would be made.
A panel of notified body experts discussed the European Commission’s Medical Device Coordination Group (MDCG) 2022-14 position paper at RAPS Euro Convergence 2023 on 12 May. The paper was released last year to help alleviate notified body capacity concerns amid the MDR and IVDR rollouts.
On the panel were Andreas Stange, senior vice president at TÜV SÜD Japan; Marta Carnielli, head of IVD certification TÜV SÜD Germany; Elizabeth Harrison, global head for IVD medical devices at BSI Group; Liz Gommans, technical and RA specialist at DEKRA Certification B.V.; and Tom Patten, certification and inspection officer for IVDs at the National Standards Authority or Ireland (NSAI). The session was moderated by Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD GmbH, and Anja Wiersma, CEO of mi-CE consultancy…