On May 26, 2021, the Medical Device Ordinance came into force. All EU manufacturers therefore have to comply with specific Swiss requirements per MedDO and the appointment of a Swiss-AR for all medical devices imported into Switzerland. As your new Swiss-AR epmodex will support you.
With the termination of the negotiations of the Federal Council with the European Union (EU) on the Institutional Agreement (InstA) on May 26, 2021, the temporary Medical Device Ordinance (MedDO) has been automatically installed.
The appointment of a Swiss AR cannot happen overnight. Even once the manufacturer has identified the most convenient entity in Switzerland, the designation process entails, at a minimum:
- Contract negotiation.
- Setting up internal procedures in the manufacturer’s Quality Management System to describe the communication processes.
- Agreement on the logistics to ensure the most suitable means of sharing information and documents (including the medical device’s Technical Documentation).
- Implementing the Swiss Authorised Representative’s particulars on the device labelling, as required.
It is therefore recommended that manufacturers based outside of Switzerland or currently represented by a European Authorised Representative not based in Switzerland start the process preparation as soon as possible.
