ARTICLE SUMMARY:
The EU Parliament and Council are just starting work on the European Commission’s proposals to comprehensively reform the MDR and IVDR now that translated texts are ready. Leaders from both bodies say they know quick work is needed, but warn the process is unpredictable.
Leaders in the EU legislative process say they will push as quickly as possible to reach agreement on a package of reforms to simplify the Medical Device and IVD Regulations, but they won’t commit to a specific timeline for enacting the comprehensive changes.
Neophytos Charalambides, minister of health for Cyprus, which is the country currently tasked with leading the Council of the EU, and Tomislav Sokol, a key member of the European Parliament on the Committee on Public Health, appeared on stage together during a March 16 event hosted in Brussels by the European Commission to discuss its recent MDR/IVDR proposals that would broaden acceptable data requirements, restrain notified body activities, add new accelerated pathways, update regulatory governance, and make an array of other reforms.
