- 14 June 2022: European regulation of medical devices – introduction
This session will focus on general concepts of medical devices according to the European Regulation (EU) 2017/745 on Medical Devices (MDR). The definition of a medical device, the process to obtain CE mark, the main applicable standards and the regulatory stakeholders will be discussed. The session will not go in detail on clinical studies with medical devices.
- 21 June 2022: Clinical studies with medical devices
This session will focus on the regulatory framework of clinical studies with medical devices according to the European Regulation (EU) 2017/745 on Medical Devices (MDR). The application process for EC/FAMHP approval, content of the submission dossier and the principles of good clinical practice (ISO14155) during a clinical study with medical devices will be discussed.
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