Meet Regulatory Requirements with the Leading
Swiss Authorized Representative (CH-REP)

Optimize your operation with MedEnvoy as your Swiss Authorized Representative for medical device and IVD companies.

Swiss Authorized Representative (CH-REP)

Why do you need a CH-REP? Switzerland was never a member of the European Union but has traditionally ensured a smooth bilateral flow of goods across borders using a Mutual Recognition Agreement (MRA) with the EU. When the EU Medical Device Regulation (MDR) took effect, the MRA was not renewed.

Although the Swiss had updated their Medical Device Ordinance (MedDO) and In Vitro Diagnostic Medical Devices (IvDO) to transpose the MDR/IVDR into Swiss law, the lack of an MRA meant Switzerland became a “third country” like the UK. That is why medical device and IVD manufacturers without a registered office in Switzerland must appoint a local Swiss Authorized Representative.

Swiss Authorized Representative for Medical Devices and IVDs

As your Swiss Authorized Representative, we will:

Advise you on labeling changes to comply with MedDO and IvDO requirements.
Review your labeling to ensure ongoing compliance.
Assist in device registrations with Swissmedic.
Fulfill vigilance and incident reporting requirements required of CH-REPs.
Cooperate with Swissmedic if reportable incidents occur.

FAQs

Why is a Swiss Authorized Representative necessary?

If you do not have a place of business in Switzerland, you must appoint a CH-REP to place medical devices onto the market as it is required by Swiss regulations.

Are there special qualification (industry experience or education) requirements for the Swiss Authorized Representative?

No. Art.51 Par.1 of the MedDo as amended simply refers ot Art. 11 of the MDR. However, to be able to perform the tasks elaborated in that article, it is obvious that the AR has to have in-house adequate experience and skills to perform the tasks. Were that not the case, the liability referred to in par. 5 of the MDR would be unsupportable.

Does Switzerland have an equivalent of the Person Responsible for Regulatory Compliance (PRRC) as exists in the EU?

Yes, it does. Art. 49 par. 2 of the MedDo specifically refers to Art. 15 MDR, including the qualifications mentioned there. However, in an unexpected gesture to the EU, the PRRC of the CH REP may be based in the EU, should the CH REP so decide.

Does the Swiss Authorized Representative need to have their own Person Responsible for Regulatory Compliance (PRRC)?

Yes, the Swiss CH-REP needs to have their own PRRC, independent from the manufacturer.

Do we need a Swiss Registration number?

To mitigate the consequences of loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorized representatives and importers domiciled in Switzerland to register once with Swissmedic. After the successful review of the information, Swissmedic will assign a Swiss Single Registration Number (CHRN) to the applicant.

Where should we indicate our Swiss Authorized Representative on our devices?

The CH-REP has to be on a labeling component that will be available to the end-user at the point of use, e.g. shelf box or sterile packaging, preferentially but not mandatorily on the device label. The CH REP may be on the IFU, if the IFU accompanies the product to the point-of-use, similar to the European Authorized Representative.

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