ARTICLE SUMMARY:
In this week’s Pathways Picks: The EU finalizes tighter requirements for notified bodies, with compromises from an earlier proposal; Europe’s breakthrough device pilot launches; digital labeling initiative; UDI in EHRs; eSTAR clarifications; FDA upgrades AI and data tools; China trial exemptions; structured submissions in Canada; and more.
Notified Body Rules
Keeping NBs more uniform, but with more leeway than proposal:
EU notified bodies will be subject to tighter requirements for conformity assessments and expense monitoring starting in 2027, but the rules are looser compared to what policymakers had proposed last year.
The European Commission finalized its implementing regulation May 5 to establish “uniform” requirements for the assessment bodies under the Medical Device and IVD Regulations (MDR/IVDR). Notified bodies bristled at the proposed rules when they were published in December, complaining that their hands would be tied by the strict mandates on processes, timelines, and costs of carrying out technical documentation reviews and quality audits.
In the final version, policymakers added more leeway, for instance, granting bodies additional “interruptions” to stop the review clock during conformity assessments, more time to complete re-certification reviews, and simplified requirements for monitoring timelines and costs. The regulation also newly introduces the option for notified bodies and companies to engage in a “rolling review” process where segments of the technical documentation file can be submitted in agreed-upon phases.
The implementing regulations are intended as a lead-in to more comprehensive proposed legislative reforms that notified bodies have complained would go too far in removing safety oversight functions and place smaller bodies at financial risk.
