The European Association of Medical Devices Notified Body (Team-NB) is concerned that certain proposed changes in the upcoming revisions of the EU’s Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) could compromise patient safety.
According to an article posted on the Regulatory Affairs Professional Society (RAPS) website, Team-NB shared its concerns with the European Commission about specific changes in the proposed revisions intended to reduce the potential for medical device shortages across the EU.
Specifically, “the proposed measures jointly reduce notified body involvement across certification and surveillance activities,” including less surveillance, less sampling, less in-depth reviews, less review of clinical information at various stages, and less unannounced audits.
According to Team-NB Director Francoise Schlemmer, “viewed cumulatively, these changes would lower regulatory oversight to a level below that applied under the Directives…shifting the EU systems from a preventative to a predominantly reactive model.