ARTICLE SUMMARY:
In this week’s Pathways Picks: A proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain; notified bodies’ guide on IVD-instrument pairs; a EUDAMED snapshot; CMS announces insurer agreements and pay rates for its ACCESS digital health model; South Korea updates wellness product v. medical device policies; and more.
Europe Picks
Indefinite CE mark recognition in Britain and more:
Great Britain won’t quit the CE mark. Manufacturers could continue to rely on CE marks granted under the EU Medical Device and IVD Regulation indefinitely to market products in Great Britain if a February 16 proposal from the UK Medicines and Healthcare products Regulation Agency is finalized. The formal consultation follows through on previously signaled plans by the MHRA to remove deadlines to transition to a UKCA mark. Under current transitional arrangements linked to the UK’s new device premarket regulatory framework (set to be adopted this year), devices certified under the MDR or IVDR, but not the UK rules, will be able to be placed on Great Britain’s market through 2030. The new proposal would remove that date with the only question left open for the limited number of products that fall into a higher risk class in Great Britain compared to the EU. MHRA is asking for input on whether those products should also be allowed on the market with an EU certificate or whether they should be subjected to a streamlined “international reliance” review. The agency also proposes to update its transitional arrangement to allow devices certified under the legacy EU Medical Device Directives to transition to the MDR by December 31, 2028, in alignment with current EU rules.
