What does MEDDEV 2.7 rev. 4 mean? | Scilife

Medical device manufacturers who want to sell their devices on the EU market must draft and maintain a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745). The clinical evaluation report is a critical step for CE marking of medical devices and during the lifetime of the device - it must be updated continuously. While the EU MDR does describe clinical evaluations for medical devices, extensive guidance can be found in MEDDEV 2.7 rev. 4, issued in...