Swiss Representative (CH-REP)

Swiss representative (CH-REP)

Schnell Medical offers to our partners as well as third parties the service as a Swiss representative. As an ISO 13485-certified company with over 30 years of experience in the medical trade, we are ideally suited for this service and can competently advise and support our customers and partners.

the initial situation

Switzerland has revised its Medical Devices Ordinance (MepV) to adapt it to the EU MDR (Reg. (EU) No. 2017/745) and to come into force on May 26, 2021.

Depending on the risk classification, non-Swiss manufacturers need an authorized representative based in Switzerland (Swiss Rep for Swiss Authorized Representative) in order to be able to sell their CE-marked medical devices in Switzerland. To be able to continue to offer our customers the widest possible range of products and also to give third parties access to this service, Schnell Medical has decided to register as an ISO 13485-certified company for this service. Since then we have been successfully offering this service to both our own partners and third-party companies. Thanks to our many years of experience in the field of medical technology, we can access a great deal of specialist knowledge and give our customers and partners competent advice.

Due to the non-update of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, which includes the EU MDR, medical device manufacturers based outside of Switzerland must authorize a Swiss Rep according to the revised MepV.

Once the mandate has been accepted, the Swiss authorized representative acts as the representative of the foreign manufacturer vis-à-vis the responsible Swiss authority, Swissmedic, and is jointly liable with the manufacturer for defective products. Schnell Medical offers you comprehensive Swiss Rep services including advice and support for the measures to be implemented (e.g. labelling, adjustments to documents) at a fair price.

What sets us apart

As a marketer, Schnell Medical is used to taking full regulatory responsibility for medical devices as part of their separate services.
Schnell Medical has a full ISO 13485 certified quality management system.
Our customers benefit from our many years of experience in the Swiss medical trade.
Schnell Medical supports you with questions and acts as a close contact to the Swiss authorities.