Introduzione
Clinical regulatory changes came along with the EU Medical Devices Regulation 2017/745 (MDR), EU Medical Devices (MedDev) and 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 and guidance on clinical evaluation and claims associated with devices.
The training further describes how to prepare the new requirements from a clinical perspective with a focus on high-risk devices but also exemptions from clinical data for low-risk devices including interactions with notified bodies and guidance on clinical evaluation for legacy devices, claiming of equivalence and requirements for post market clinical follow-up (PMCF).
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), labelling and marketing claims.