ARTICLE SUMMARY:
In this week’s Pathways Picks: The first EUDAMED registration requirements take effect this week, as some other important EU IVDR and MDR deadlines pass; Democratic lawmakers challenge medtech prior authorization pilot; FDA partially recognizes the recent revision to a key biocompatibility standard; and more global medtech policy updates.
EU Milestones
Important deadlines this week:
EUDAMED day. Starting tomorrow, all companies selling devices in the EU must register on the EUDAMED database, and they also need to start entering any newly introduced device, by unique device identifier (UDI), into the database before market launch. The May 28 deadline for mandatory registration in four modules of EUDAMED hits after years of delay in getting the system fully operational and validated. In addition to the Actor and Device/UDI modules, a mandate for notified bodies to register new device certifications in the Notified Body/Certificate module kicks in Thursday. Finally, national competent authorities must start entering device safety information into the restricted-use Market Surveillance module this week. Some other key points on the EUDAMED transition:
- For devices that were already on the market prior to May 28, companies have until the end of November to register them.
- Notified bodies have until next May to register certificates granted prior to Thursday.
- As of May 27, more than two million UDIs are registered, almost double the number from the February, when Market Pathways last reviewed the database. There are also about 46,000 economic operators (mostly manufacturers) and 2,841 certificates registered.
- The long-term vision for a comprehensive EU-wide device database is still not fully realized, as there are two remaining database segments, for tracking Post-Market Surveillance/Vigilance, and Clinical Investigations/Performance Studies, still in development.
