EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation
Executive Summary
TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.
You may also be interested in...
Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions
The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.
EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.