EU MDR reform package: conformity assessment, EUDAMED and predictability changes
Key Questions
What key changes are proposed in the EU MDR reform package?
EC drafts from February–March 2026 propose revisions to certificate caps, risk-based surveillance, and flexible clinical evidence requirements. They also introduce Medrais for clinical investigations under Art 52 and PMCF.
When does EUDAMED become mandatory, and what modules are affected?
EUDAMED becomes mandatory on May 28, 2026, covering SRN, UDI, certificates, and technical documentation modules. Manufacturers should prepare QMS and PMS systems accordingly.
What is the extension for IVDR Class C legacy devices?
IVDR Class C legacy devices can remain on the market until December 2028 if manufacturers take active steps toward compliance. Additional updates include ~30-day vulnerability reporting and ISO 20417:2026 standards.
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, April 2026 standards pipeline. NB crunches, DPP ties, recent CE marks; prepare QMS/PMS/IVDR transitions.