ARTICLE SUMMARY:
In this week’s roundup: Last-minute meeting scheduled to discuss potential extensions on EU Medical Device Regulation compliance, an active week for medtech cybersecurity discussions, eyeing a divided Congress, CMS postpones planned coverage with evidence development meeting, and more from FDA, China, and Saudi Arabia.
Top Pick: Emergency MDR Meeting
EU policy group convenes to consider compliance extensions:
EU medical device policy advisors were called together November 17 with little pre-planning to discuss the prospects of a coordinated approach by EU member states to grant legacy devices more time to comply with the Medical Device Regulation. The emergency meeting of the Medical Device Coordination Group was convened as pressure builds to address a growing bottleneck of MDR CE mark reviews in the face of limited notified body capacity.