Switzerland in Europe, but without access to EUDAMED
As a result of the entry into force of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR), the agreement on trade in CE-marked products (i.e., medical devices) between the European Union and Switzerland, known as the Mutual Recognition Agreement (MRA), has expired. The regulations in Switzerland, known as the Medical Devices Regulation, SR 812.213 (MedDO), and the In Vitro Diagnostics Regulation, SR 812.219 (IvDO), were updated and implemented on May 26, 2021 and May 26, 2022, respectively. As a result, Switzerland does not have access to the European Medical Device Database (EUDAMED).
What is a CH-REP?
A CH-REP is an individual or legal entity in Switzerland that receives and accepts written authorization from a manufacturer based in another country to act on behalf of the manufacturer with respect to tasks in accordance with Swiss MedDO / IvDO regulations.
Why should a manufacturer appoint a CH-REP?
The manufacturer should appoint a CH-REP because MedDo/IvDO regulations require the appointment of an Authorized Representative for a manufacturer from the European Economic Area that is not based in Switzerland. Together with the Swiss importer, they are listed on the label of the medical device being marketed (packaging or document accompanying the product), providing the appropriate contact for the Swiss patient, hospital or Swiss authority.
What are the responsibilities of the CH-REP?
The CH-REP’s responsibilities are to verify that the medical device complies with Swiss regulations. This is an essential step before a medical device is placed on the market. Since the CH-REP is responsible for the safety aspects of the medical device, CH-REP should review the documentation.
How is the CH-REP different from the EU REP and UK RP?
CH-REPs differ from EU REPs and UK RPs in the territories in which they operate and the legal legislations whose requirements they should implement. CH-REP is an Authorized Representative for the Swiss market, EU REP is an Authorized Representative for the entire European Union market, and UK RP is an Authorized Representative for the UK market.
How to designate a Swiss Authorized Representative?
To designate a Swiss Authorized Representative (Swiss AR, CH-REP) parties should agree upon every obligation in the contract, as the CH-REP is responsible for both the formal and safety aspects of placing the product on the Swiss market (51(2) MedDo). The CH-REP represents and acts on behalf of the manufacturer in Switzerland.
A contract is signed between the Manufacturer and the CH-REP with specified responsibilities. This agreement takes into account the tasks specified in MedDo/IvDO and EU MDR/IVDR. From this date, CH-REP data can be used on the label or in a document attached to the product.
Can a CH-REP be appointed if the Manufacturer already has an EU REP?
Yes, CH-REP can be appointed if the Manufacturer already has an EU REP. These are two separate positions. Like the EU, Switzerland requires the appointment of a Swiss authorized representative.
CH-REP’s role in medical device registration and post-market surveillance (PMS)
The CH-REP’s role in medical device registration and post-market surveillance is to monitor regulatory aspects that may affect its client. Following the abolition of the MRA, Switzerland introduced new obligations for the marketing of medical devices in the Swiss market. These obligations reflect the MDR/IvDR regulations.
Switzerland and Swissmedic (the competent authority) accept the EU declaration of conformity, which means that the issuance of a Swiss declaration of conformity is not necessary.
Switzerland also accepts the latest Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to transitional provisions for certain medical devices and in vitro diagnostic medical devices.
What does the cost of appointing a CH-REP depend on?
The costs of appointing a CH-REP depend on the risk class of the medical device and the number of devices produced.
What are the steps of registration of medical devices in Switzerland?
Steps of medical device registration in Switzerland:
- review of product documentation for compliance with Swiss and European regulations,
- support in completing the CE marking process,
- obtaining CE marking,
- entry into the Swiss market.
How can we help?
We can help you prepare to be compliant with medical device laws in Switzerland. Contact us if you intend to export products to the Swiss market and need the support of an Authorized Representative (CH-REP, Swiss AR) to adjust your documentation to the requirements of the medical device law in Switzerland.