Significant regulatory changes came along with the EU Medical Devices Regulation 2017/745 (MDR), EU Medical Devices (MedDev) guidelines and EU Medical Device Coordination Group (MDCG) guidance evolutions affecting the clinical evaluation of medical devices.
This online course gives participants an overview of the requirements for sufficient clinical data for medical devices and the impact of the MDR, guidelines, and guidance on clinical evaluation. The training further describes how to prepare the new requirements from a clinical perspective, including the MedDev 2.7.4/1 on clinical evaluation and the MedDev 2.12/2 on post-market clinic follow-up, as well as MDCG guidance on clinical evaluation for legacy devices, and claiming of equivalence.
The training will allow participants to understand the regulatory requirements clearly. It will give hands-on insight into how to achieve compliance with respect to the changing environment and interaction of documents such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).