Presentation of the regulatory framework that regulates performance studies of medical devices for in vitro diagnostics and what is current in Sweden.
- The regulatory framework (horizontal)
- Mission and role of the authorities
- Notification and application to the MPA when several regulations need to be applied simultaneously (e.g. CTR and IVDR).
Lecturer: Anna Skott, Regulatory Investigator Medical Devices, Medical Products Agency.
The format is a 45-minute lecture followed by a 15-minute question and answer session. The webinars are open to everyone, but are mainly aimed at small and medium-sized enterprises (SMEs) and academic researchers in the field of pharmaceuticals and medical devices.
Read more and register here.
