Swiss Authorized Representative (CH-REP)
The Swiss Authorized Representative is required by the Swiss Authorities for Medical Devices & In Vitro Diagnostic Medical Devices Manufacturers located outside of Switzerland. In order to place medical devices in the Swiss market, you need to appoint a Swiss Authorized Representative (CH-REP).*
As a Swiss Authorized Representative, MDSS CH GmbH is the main contact for the Swiss Authority. MDSS CH GmbH is the responsible for the formal and safety-related issues connected with the placing of medical devices in the Swiss market.
Authorised representative; “natural or legal person in Switzerland who has been mandated in writing by a manufacturer established in a foreign country to act on the manufacturer’s behalf in relation to specified tasks in accordance with Art. 4 para. 1 let. g from MedDO and with Art. 4 para. 1 let. f from IvDO .”
MDSS CH GmbH is Your Swiss Authorized Representative:
- Verification of devices – Check that declarations of conformity and TD have been drawn up and that conformity assessment procedures have been carried out (certificates)
- Registration of economic operators
- Traceability of devices
- Report serious incidents and safety corrective actions in Switzerland to Swissmedic, trend reports
- Immediate forwarding of complaints and reports about suspected incidents to the Manufacturer
- Register of complaints, non-conforming devices, recalls and withdrawals
- Cooperate with Swissmedic in all preventive or corrective actions
- Documents retention requirements
If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO and Art. 44 para. 1 IvDO). This also applies to manufacturers with their registered place of business in the EU.
As your Swiss Authorized Representative (CH-REP) we will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.
Contact MDSS CH GmbH
- Address Laurenzenvorstadt 61, 5000 Aarau, Switzerland
- Email email@example.com