ARTICLE SUMMARY:
In this week’s roundup: EU updates, including the first aesthetic device to get through the MDR, MedTech Europe’s call for comprehensive reforms, and a notified body from Turkey; tidbits from Medicare physician, hospital outpatient, and home health pay rules; FDA underscores legacy device cybersecurity requirements; and updates from Mexico, China, and the UK.
EU Picks
Push to reform, an MDR first, a Turkish notified body:
EU medtech seeks comprehensive reforms. MedTech Europe doubled down and expanded on demands for “comprehensive reform” of the EU Medical Device and IVD Regulations in a position paper published November 7. “While considerable work has been done by all stakeholders to address the short-term implementation challenges, there are structural issues in the regulatory system which make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation,” the trade group writes. The paper reaffirms some reform requests outlined in an open letter sent in September to the EU Health Commissioner by 34 organizations including MTE and adds more changes for consideration. Key reforms floated by the industry trade association include:
- Allowing notified bodies to be more flexible in weighing benefits and risk when assessing devices
- Removing the need to recertify devices under the MDR and IVDR
- Allowing pre-submission dialogues with notified bodies
- Establishing accelerated and precertification pathways
- Building more centralized governance for addressing systematic regulatory issues
