ARTICLE SUMMARY:
In this week’s Pathways Picks: Notified bodies and other EU groups oppose expanded “well-established technology” exemptions; CMS opens coverage analysis for a novel CRT device; FDA plans more 510(k) exemptions; South Korea clarifies transitions for digital health product labeling under a new law; and more medtech policy updates.
Europe Picks
Notified bodies—more pushback, updated consensus guide:
WET exemptions opposed. EU notified bodies, doctors, and insurers say the European Commission went too far earlier this year in expanding Medical Device Regulation exemptions. Six groups, including TEAM-NB, the Standing Committee of European Doctors, and the European Social Insurance Platform, issued a joint statement June 8 objecting to the Commission’s March 20 regulations that designated dozens of new device categories as “well-established technologies” (WET).
The Commission expanded the WET list of both Class IIb devices, allowing them to bypass some technical documentation review requirements, and Class III devices, exempting them from clinical investigation requirements. The groups criticize the Commission for designating generic product groups rather than more specific devices. They say that causes confusion about what qualifies and makes it more likely products will reach the market without proper scrutiny. The June 8 statement cites atrioseptostomy catheters and bone substitutes as two newly added WET categories that are associated with safety concerns or require special precautions, depending on the device. “The proposed list cannot be supported in the current form and requires substantial revision to ensure legal certainty,” the groups write.
The Commission enacted the WET expansion as part of a series of updates intended to streamline regulatory requirements in advance of broader reforms that are being pursued via legislation. Notified bodies have also pushed back against multiple provisions within the legislative proposals, warning they go too far in removing oversight that protects patient safety.
