ARTICLE SUMMARY:
The European Medicines Agency will launch a year-long pilot next month to give 10 makers of innovative devices the opportunity to get early feedback from EU expert panels on clinical trial planning to facilitate the MDR assessment process.
Ten early-stage, high-risk devices will have the opportunity to get scientific input from experts on clinical trial plans over the next year, with an eye toward facilitating certification under the EU Medical Device Regulation. On February 27, companies will be able to start submitting letters of interest to participate in the European Medicines Agency scientific advice pilot, officials announced during a January 25 webinar.
