EU MDR reform package: conformity assessment, EUDAMED and predictability changes
Key Questions
What are the proposed changes to EUDAMED under the EU MDR reform?
EUDAMED becomes mandatory on May 28, 2026, requiring registration of SRN, UDI, certificates, and technical documentation. The reform package includes revisions to certificate caps, risk-based surveillance, and flexible clinical evidence requirements. Manufacturers should prepare their QMS and PMS for these transitions.
What is the extension for legacy Class C IVD devices under IVDR?
Legacy Class C devices can remain on the market until December 31, 2028, provided manufacturers take active steps toward compliance. This extension supports ongoing transitions amid notified body crunches. Check progress with tools like 'Is Your Class C IVD Transition on Track?'.
What new requirements are proposed for vulnerability reporting and clinical evidence?
Vulnerability reporting must occur within about 30 days, aligning with ISO 20417:2026 standards. The reforms introduce flexible clinical evidence options and Medrais for clinical investigations under Art 62 and PMCF. Guidance is available on clinical evidence requirements for higher-risk classes.
EC drafts (Feb–Mar 2026) propose certificate cap revisions, risk-based surveillance, flexible clinical evidence; EUDAMED mandatory May 28, 2026 (SRN/UDI/certs/tech docs); Medrais on clinical investigations Art 52/PMCF; IVDR Class C legacy extension to Dec 2028 if active steps; ~30-day vuln reporting, ISO 20417:2026. NB crunches, DPP ties, recent CE marks; prepare QMS/PMS/IVDR transitions.