ARTICLE SUMMARY:
Nine European countries presented a top-line MDR/IVDR reform proposal to the EU Council that would give more centralized device authority to the European Medicines Agency and seek to remove some “administrative obligations” for companies. The proposal comes at the start of a new term of the European Commission that includes a remit to consider legislative changes to the device regulations.
Health ministers from France, Germany, Ireland, and six additional EU countries presented a broad-based proposal to reform the Medical Device and IVD Regulations to the Council of the EU on December 3. The plan would assign more centralized authority to the European Medicines Agency (EMA) and would seek to remove “administrative obligations” that slow access to new technologies.
The Employment, Social Policy, Health, and Consumer Affairs (EPSCO) section of the Council, which represents health ministers from all the EU member states, slotted in an agenda item to consider the nine-country proposal during its December 2-3 meeting. The EPSCO gathering came just as European Commissioner Ursula von der Leyen started her second term leading the EU December 1, with a new health commissioner and a mandate to consider systematic MDR/IVDR reforms.
