Quality & Compliance
Safety & Vigilance
25 february 2022
Until recently, medical devices were able to move freely between Switzerland and the European Union (EU). But, since May 26, 2021, when the Medical Devices Regulation (EU) 2017/745 replaced the Medical Device Directive, the exchange of medical device products has become more complicated.
Although a part of Europe, Switzerland is not a member of the EU and has its own trade agreement, much like other non-EU members. Under the old directive, Switzerland and the EU were partnered through the Mutual Recognition Agreement (MRA). However, Switzerland’s decision to not formally sign the Institutional Framework Agreement, a key requirement for the continuation of the MRA, means new barriers to trade.
Without the MRA, alternative contracts are required, which will create certain challenges for both EU and Swiss manufacturers. If an EU-based company wishes to sell into the Swiss market, they must appoint an authorized representative who will act on behalf of the EU manufacturer and who is registered with the Swiss authorities. Each device requires a representative on behalf of the product. In addition to an appointed representative, manufacturers now need an importer based in Switzerland who is registered with the authorities. Labelling criteria have also tightened in line with these changes. So as well as the name of the manufacturer, the name of the authorized representative is now required.
There are also additional hurdles when Swiss manufacturers are exporting to the EU. Medical Devices need to be certified to meet standardized guidelines with a CE mark on the device to show adherence to these regulations. While CE marking from the EU that was gained under the COUNCIL DIRECTIVE 93/42/EEC will continue to be accepted in Switzerland, the same is not the case in reverse. Therefore, when exporting to the EU, new certification will be required.
The lack of an updated MRA has also impacted market surveillance, where Swiss manufacturers and authorities are no longer able to access additional patient data from the EU regarding their medical devices. Any problems with a device’s safety are now reported to the Swiss authorities, but without the benefit of the broader EU patient data.
PLG can help manufacturers to navigate these changes
ProductLife Group aid manufacturers of medical devices by providing expertise and knowledge of the industry through a dedicated team based in Switzerland. PLG can assist Swiss manufacturers who may be navigating these changes, while also offering regulatory intelligence. In addition, PLG can also act as an authorized representative to EU manufacturers who wish to sell their medical devices in Switzerland, or to provide support in registering with the Swiss authorities.
Contact us to find out how PLG can provide tailored support to help you overcome the additional hurdles presented by new Medical Devices Regulation and the decision not to continue with the MRA.
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