Swiss authorised representative Services
Since Switzerland is not a member of the European Union and no specific agreement applies anymore, Medical Device and IVD manufacturers now require a Swiss Authorised Representative (CH-REP) to enter the Swiss market if they are not established in Switzerland.
Switzerland is not a member of the European Union. Their economic and trade relations with the EU are primarily governed through a series of bilateral agreements, such as the Mutual Recognition Agreement (MRA) which includes the previous legislation on medical devices (Medical Device Directive 93/42/EEC and Active Implantable Medical devices Directive 90/385/EEC) and in vitro diagnostics (In Vitro Diagnostic Directive 98/79/EC). Within these agreements Switzerland has agreed to take over certain aspects of EU legislation in exchange for accessing part of the EU’s single market.
When the Medical Devices Regulation 2017/745 (MDR) took effect on 26 May 2021, the MRA was not renewed to also include the new MDR. Although Switzerland had updated their Medical Device Ordinance to transpose the MDR into Swiss law (MedDO), the absence of an updated MRA, or other agreement that covered the MDR, resulted in Switzerland becoming a “third country” as of the MDR date of application. The same will happen on 26 May 2022 when the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR) takes effect.
Therefore, medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative (CH-REP).
An IVD and/or MD manufacturer?
Located outside Switzerland?
Selling your products in Switzerland?
Qarad Suisse S.A. builds on Qarad’s expertise as a European Authorized Representative and UK Responsible Person, as well as on the regulatory and technical competence of the Qarad team. We act as an independent CH-REP and keep your regulatory interests separate from your supply chain.
A good CH-REP guides you through the local regulations, assists in case of regulatory actions against your company and communicates with Swissmedic.
This all requires exquisite regulatory and technical-scientific skills and a fluent communication style. Qarad’s team has adequate experience and qualities to serve as the ideal CH-REP.
The concept of a Swiss authorised representative is very similar and based completely on the European authorised representative concept in the MDR/IVDR.
Qarad has been active for many years as European Authorised Representative for more than one hundred different companies. Our assistance guarantees easy access to the Swiss market.
To separate your commercial and regulatory interests in Switzerland, it is not a good idea to appoint a Swiss Importer as CH-REP.
As an independent organization, Qarad can act as your regulatory guide.