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Significant regulatory changes are coming along with the EU Medical Devices Regulation 2017/745 (MDR), MEDDEV and MDCG (Medical Device Coordination Group) guidance evolutions affect the clinical evaluation of medical devices.
This online course gives participants an overview on the requirements for sufficient clinical data for medical devices and the impact of the MDR and guideline documents on clinical evaluation. The course 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 and MDCG Guidance on clinical evaluation for legacy devices, equivalence, and sufficient clinical data.
The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands-on insight on how to achieve compliance with respect to the changing environment and new documents to be created such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).