Recommendations for clinical investigations of high-risk medical devices in Europe

Recommendations for clinical investigations of high-risk medical devices in Europe

The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium has published new consensus recommendations today in The Lancet Regional Health Europe, that set out scientifically robust methodologies for clinical investigations of high-risk medical devices.

CORE-MD consortium announces recommendations on clinical assessment of high-risk medical devices - Interventional News

The CORE-MD—Coordinating Research and Evidence for high-risk Medical Devices—consortium has published new consensus recommendations in The Lancet Regional Health Europe, setting out scientifically robust methodologies for clinical investigations of high-risk medical devices. The recommendations respond directly to a request from the European Commission to provide expert advice on trial design, addressing a longstanding gap in guidance for the ev…