CH-REP – Swiss Authorized Representative

Swiss Authorized Representative (CH-REP)

Since Switzerland updated its Medical Devices Regulation (MepV, MedDO) and In Vitro Diagnostic Devices (IvDO) to implement the MDR/IVDR into Swiss law, Switzerland became a “third country” in Europe due to the lack of an MRA. Therefore, medical device and IVD manufacturers outside Switzerland must appoint a local Swiss authorized representative.

What does the CH-REP for me?

As a Swiss authorized representative, we handle and support you in particular with the following requirements:

Review QM System for compliance with MedDo and IvDo
Review Swiss declaration of conformity and technical documentation
Review PMS Reports and General safety and performance requirements GSPR
Review ISO and EC Certificates
Review and approve labeling, packaging and IFU
Verify that manufacturer and importer are identified
Maintain a register of complaints as required by Swiss law
Register the manufacturer and the products at Swissmedic
Cooperate with Swissmedic regarding preventive/corrective action and correspond between the manufacturer and the Swiss authorities in case of an incident.
Consulting in case you have products that are approved under MDD but your EC Certificate is expired or will expire soon and show you the conditions under which your products can continue to be placed on the market.

Have we piqued your interest? Here you will find further information about our service and the legal requirements.

A Swissmedic leaflet about obligations of Manufacturer, CH-REP and CH-IMPORTER

your application form to get us your CH-REP in Switzerland

Also need an IMPORTER for your products in Switzerland?

More questions? See our FAQ about CH-REP:

What is a Swiss Authorized Representative (CH-REP)?

A Swiss Authorized Representative is defined as being any natural or legal person established within Switzerland who has received and accepted a written mandate from a manufacturer located outside Switzerland to act on the manufacturer’s behalf in relation to specified tasks about the latter’s obligations under the regulations.

Why is a CH-REP 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.

What does it cost to register my company and my products in Switzerland?

The annual base fee for our service as CH-REP is CHF 1’500.00 per Manufacturer.

For review and approve of each generic product group an additional fee, depending on your Risk Class will be applicalbe.

Are there special qualification requirements for the CH-REP?

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 Authorized Representative 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.

Do 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 EU, should the CH REP so decide.

What are the timelines for registration in Switzerland?

After you submitted us the requested company and product documentation, it takes about 5 business days per product cathegory to review and approve the registration as CH-REP.

Do we need to change anything on our product, packages or labels to sell our products in Switzerland?

No, you don’t need to change anything. However, to apply with MDR regulations you need to label the CH-REP information on your product or package, but this can be done with an aditional sticker if a change on your current label is not applicable.

Our Products are still certified under MDD. Are we able to register them in Switzerland or do we to comply with MDR first?

Your product don’t need to be certified as an MDR to register and sell them in Switzerland. With a valid MDD certificate or certification extension the CH-REP registration can still be done.

Where do we have to print the CH-REP information?

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. For products that are still certified under MDD, 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.