Swiss Authorized Representative (CH-REP)
Are you looking for a Swiss Authorized Representative (CH-REP) for your medical devices and/or IVDs?
Qarad Suisse S.A. – part of the QbD Group – is an independent partner that can act as your Swiss Authorized Representative (CH-REP). Find out more about our CH-REP service below.
What is a Swiss Authorized Representative?
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 former 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 agreed to adopt certain aspects of EU legislation in exchange for access to part of the EU single market.
When the Medical Device Regulation 2017/745 (MDR) came into force on 26 May 2021, the MRA was not renewed to include the new MDR. Although Switzerland had updated its Medical Device Ordinance to transpose the MDR into Swiss law (MedDO), the absence of an updated MRA, or any other agreement covering the MDR, resulted in Switzerland becoming a “third country” as of the date of application of the MDR. The same will happen on 26 May, 2022 when the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR) comes into force.
Therefore, medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative (CH-REP). The Swiss Authorized Representative is responsible for the formal and safety aspects of placing the device on the market in Switzerland.
Why QbD Group?
To ensure easy access to the Swiss market, it is important to choose a good Swiss Authorised Representative who can guide you through the process.
Qarad Suisse S.A. – part of the QbD Group – builds on Qarad’s expertise as a European Authorized Representative and UK Responsible Person, as well as the regulatory and technical competence of the Qarad team.
We can act as an independent CH-REP and keep your regulatory interests separate from your supply chain.
Our team of Regulatory Experts will familiarize you with local regulations, help you with regulatory actions against your company, and communicate with Swissmedic.
All of this requires excellent regulatory and technical-scientific skills and a smooth communication style. The team at Qarad has enough experience and qualities to serve as the ideal CH-REP.
We also offer you independence. 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 guide on regulatory matters.
The concept of a Swiss Authorized Representative is very similar and fully based on the European concept of an Authorized Representative in the MDR/IVDR.
Qarad has been active for many years as a European Authorized Representative for more than a hundred different companies. Our assistance guarantees easy access to the Swiss market.
All other foreign manufacturers must designate a Swiss Authorized Representative effective May 26, 2021. These provisions apply to both MDD/AIMDD and MDR devices.
Yes, the CH-REP data must be added to the device. Depending on the class of the medical device, the CH-REP details must be included on the label and/or in the instructions for use or in a document accompanying the device. Deadlines for adding the CH-REP details also depend on the class of the device.
Currently, the IVD Directive 98/79/EC is still in effect, so the MRA covering this legislation still applies. This means that you do not need a CH-REP today for your devices covered by the IVD Directive 98/79/EC.
However, as of 26/05/2022, IVDD 98/79/EC will be repealed and only IVDR 2017/746 will be in force. A number of devices can make use of the transitional provisions of Article 110 (3) and (4) of the IVDR, but these devices should be considered to be covered by the IVDR as of the date of application and no longer by the IVDD.
This means that Switzerland will become a third country for all IVD devices as of 26/05/2022, as there is no MRA in force incorporating the IVDR. The timetable for the designation of a CH-REP for IVDs is not yet known as the Swiss regulation covering IVDs has not yet been published.
Contact us for more information or request a free, no-obligation proposal.