ARTICLE SUMMARY:
EU expands the “well-established technologies” list subject to simplified rule. Excerpted from Pathways Picks March 25: Deregulation in the US and EU, Digital Health Roundup, and More.
The European Commission followed through on plans to expand the number of devices that benefit from a simplified regulatory pathway for “well-established technologies” (WET, as commonly referred to in the EU) under the Medical Device Regulation. It published two Delegated Acts March 20 adding dozens of new WET devices to the 12 (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors) that were included in the original MDR. Under the new rules, devices like cranial perforators and implantable pulse generator magnets will not require clinical investigations even when they are Class III devices and products like suture buttons and bone substitutes won’t be subject to requirements for notified bodies to assess documentation for every device even though they are Class II implantables. The regulations are part of the Commission’s efforts to enact streamlining measures more quickly while lawmakers debate more fundamental reforms to the MDR and IVDR.