ARTICLE SUMMARY:
In this week’s Pathways Picks: EU MDR group meets in advance of May 26 submission deadline; guidance documents related to EU performance studies and clinical investigations; CDRH builds Home as a Health Care Hub, and issues a biocompatibility analysis dataset; items from the Medicare inpatient rule; and updates from Germany, Australia, and China.
EU picks
Key gathering, reforms advance, and guidance docs:
EU eyes May transition. Companies selling devices authorized under the legacy EU directives have until May 26 to get their Medical Device Regulation submissions in to notified bodies or they’ll have to take the products off the market. The EU Medical Device Coordination Group (MDCG), which brings together individual country and EU device officials, is meeting April 24 to discuss planning and potential impacts from this deadline. Originally, the May 2024 date marked when legacy devices needed to be authorized under the MDR to remain on the market but the timelines were extended last year. Still, not every manufacturer will meet the deadlines to submit applications by next month and secure a written agreement with notified bodies by September. During its Wednesday meeting, officials will hear updates on the ongoing EU study tracking the “availability” of devices and competent authorities will be “encouraged to share information and to discuss the practical steps for sharing information on discontinuations of medical devices during the transitional period”. MDCG will also hear an update on pending legislative proposals to extend IVDR transition times, allow for a gradual, rather than all-or-nothing, EUDAMED rollout, and implement new product shortage disclosure policies for manufacturers.
