The medical technology industry finds itself exposed to increasing regulations. The European regulations (Medical Device Regulation, MDR) and the Swiss provisions (Law on Therapeutic Products – HMG; Law on Human Research – HFG; Ordinance on Medical Devices – MepV) with entry into force on 26 May 2021 in particular are keeping the industry very busy. The expert group Regulatory Affairs (EG RA) provides the medical technology industry with its specialist knowledge and supports the Office in matters concerning Regulatory Affairs. The EG RA primarily acts as a platform for exchange for thematic working groups. In contrast, the Office performs the Association’s strategic tasks and ensures general communication with its members, the industry, the media and other stakeholders.
Who we are
The expert group Regulatory Affairs brings together member companies of Swiss Medtech that are interested in RA matters and provides sufficient knowledge in the specialist field at a senior level.
Who can participate
Employees of Swiss Medtech member companies with expertise in the field of Regulatory Affairs (RA) or who are interested in RA matters.
- Acting as an exchange platform for its members and representing the interests of the members at Medtech Europe – primarily in the fields of Regulatory Affairs (RAC), Post Market Surveillance (PMS) and Clinical Affairs (CIT)
- Informing members on the latest developments at Medtech Europe and in global markets
- Representing the interests of the members through active involvement in standardisation work at a national, European and international level (SNV, EN and ISO)
- Ensuring the provision of information on market authorisation provisions, in particular regarding the interpretation of legal provisions in the most important global sales markets of the export industry. The expert group RA does not participate in advisory activities, neither for members (individual interests) nor for third parties
- Promoting industry knowledge in the fields of Regulatory Affairs and standardisation
- Assisting with compiling position papers and recommendations from the Office
- Supporting the Office in connection with revisions of Swiss legislation and, where possible, international legislation
- Assisting with the implementation of related information events of the Office as well as with further activities as part of specialist working groups (taskforces)
- Participating in Swissmedic’s Round Table on Regulatory Affairs