CH-REP - Regulatory Affairs - QbD Group (2)

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)

What is a Swiss Authorized Representative?

KEY TO PLACING YOUR DEVICE ON THE SWISS MARKET

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 has happened on 26 May, 2022 when the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR) came into force.

Therefore, medical device and IVD manufacturers without a registered office in Switzerland must 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.

How can we support you?

OVER 20 YEARS OF EXPERIENCE IN MD & IVD

Qarad Suisse S.A. – part of the QbD Group – builds on expertise as a European Authorized Representative and UK Responsible Person, as well as the regulatory and technical competence of the team.

We can act as an independent CH-REP and keep your regulatory interests separate from your supply chain.

What we offer

Independent representation:
- We act as an independent CH-REP to maintain a clear separation between your regulatory and supply chain interests.
- Avoid potential conflicts of interest associated with appointing a Swiss importer.
Comprehensive support:
- Expertise in Swiss regulations and guidance tailored to your needs.
- Assistance in managing regulatory actions taken against your company.
- Direct communication with Swissmedic on your behalf.

Why partner with QbD Group?

Proven competence:
- Decades of experience in regulatory compliance.
- Strong technical-scientific skills combined with effective communication capabilities.
Alignment with European standards:
- The CH-REP concept mirrors the European MDR/IVDR framework, and Qarad’s expertise ensures a smooth transition.
A trusted partner for Swiss market access:
- Over 100 companies have trusted us for regulatory representation in Europe.
- Our proven methods guarantee easy and efficient access to the Swiss market.

CH-REP - Regulatory Affairs - QbD Group (1)

According to the MDR, I have older devices for which I have a valid certificate from a notified body. Do I need to designate a CH-REP for these devices as well to access 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.

Should the CH-REP be added to the device labelling?

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.