Medical products that are sold outside the European Union must undergo conformity assessment procedures that differ from standards in the EU. MDR Regulator, together with its subcontractors, provides expert advice and support in obtaining permits and registrations in foreign markets.
As of May 26, 2022, all manufacturers of medical devices and IVDs are treated the same as manufacturers of these devices not based in an EU member state. In the other direction, the situation is similar, i.e. in order to launch a product on the Swiss market, companies need to appoint a Swiss Representative. With our new service, manufacturers can introduce medical devices in the EU, Switzerland, as well as the UK,” says Katarzyna Wesołowska, CEO of MDR Regulator Sp. z o. o.
The EU CE marking process allows a product to enter the Swiss market.
As part of the process, CH-REP is responsible for verifying that a medical device complies with Swiss regulations. This is a necessary step before a medical device can enter the Swiss market. Since the CH-REP is responsible for the safety aspects of the medical device, it must review the documentation.
With that said, only the Swiss manufacturer, Swiss authorized representative (CH-REP), CH importer are required to register with Swissmedic. After registration, a CHRN is issued (as SRN in EUDAMED). Once registered with Swissmedic, the Swiss authorized representative acts in Switzerland on behalf of the manufacturer.
Only custom-made devices must be registered with Swissmedic.
CH-REPs are not required to register another device on behalf of the non-Swiss manufacturers they represent. To summarize: if a non-Swiss manufacturer designates a CH-REP and does not manufacture custom-made devices, there is no need for further registration. Once all requirements are met, the CH-REP passes the information to the manufacturer and can act on its behalf in Switzerland. The CH-REP can also monitor any regulatory updates that may affect their products.
At the same time, 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), expired. The MRA covered the recognition of conformity assessments of medical devices in bilateral trade with the EU.
As a result, this situation has led to Switzerland losing access to the European Database on Medical Devices (EUDAMED), which results in less security for imported medical devices. At the same time, a Swiss medical device manufacturer is only allowed to trade with the EU after appointing an EU authorized representative and an EU importer.
Admittedly, the Swiss market is smaller than in other EU countries. However, the Swiss healthcare system is considered one of the best in the world. The exceptionally high standard of health care is also due to the fact that private health insurance is in force (there is no free health care services or insurance tax system). What’s more, private health insurance is mandatory for anyone living in Switzerland and completely private regardless of whether a (foreign) patient is treated. This also means that prices for any healthcare service, including medical devices and pharmaceuticals, are higher than in other countries. Since Switzerland’s currency (CHF) is considered stable, trading medical devices to Switzerland can be considered a favorable option.