Medical device research update after the adoption of the EU legislation (MDR).

Abstract

Despite the 2017 update to European medical device regulation and its entry into force in 2021, many doubts persist about its real-world application in medical device (MD) research in Spain. The development of MDs requires collaboration among numerous stakeholders, including researchers, ethics committees, notified bodies, the Spanish Agency of Medicines and Medical Devices, manufacturers, and other involved parties-all of whom have had to adapt to the new regulatory framework. This has required