ARTICLE SUMMARY:
In this week’s Pathways Picks: Reform efforts elevate, transition date passes, and cell/tissue bill is adopted in the EU; the UK envisions new medtech market access pathways; New Zealand eyes repeal of health products framework; and more global medtech policy news.
EU Picks
Legislation and guidance:
Surveillance guidance updated. Device surveillance duties by notified bodies that are not designated under the Medical Device Regulation will end on September 25 of this year, an updated EU guidance clarifies. Under the current transition calendar, companies had until this past weekend to submit MDR applications to notified bodies to keep devices on the market under legacy EU directive certificates and they have until September 26 to sign a written assessment agreement with an MDR body. That latter date marks when non-designated notified bodies are no longer in charge of legacy devices, the May 27 revised guidance on “appropriate surveillance” of legacy devices states. The guidance was updated to reflect the details of the transitional calendar that was set into law last March, allowing qualifying legacy devices to be placed on the market through 2027 or 2028.
