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Selling Your Medical Devices in Switzerland? Common Scenarios that Get Manufacturers Into Trouble

Up until the new EU Medical Device Regulation (MDR) went into effect in May 2021, the European Union and Switzerland operated under a Mutual Recognition Agreement (MRA). This allowed non-Swiss companies to bring their CE marked devices into Switzerland as long as they met EU regulations. The two sides could not agree on renewing the MRA and as a result the Swiss are now enforcing their own medical device regulations just as the United Kingdom has done. The good news is that the Swiss medical device regulation emulates the EU Medical Device Regulation. Still there are a few common situations that get manufacturers into hot water with their Notified Body.

You are actively selling devices in Switzerland that hold European CE Marking certificates under the MDD…

While many QA/RA professionals have heard about the need to appoint an EU importer as prescribed in Article 13 of the MDR and IVDR, far fewer know that Swissmedic also mandates that ALL MANUFACTURERS appoint a Swiss importer plus a Swiss-based Authorized Representative. Yes, it’s true that you may continue to market medical devices in Switzerland holding valid CE certificates in compliance with the EU Medical Devices Directive (MDD). That’s perfectly acceptable until that certificate expires or May 2024, whichever comes first. However, it does not matter whether you hold existing certificates in compliance with the MDD or MDR, you are still required to appoint a Swiss importer and Swiss Authorized Rep (CH-REP). Here’s more detail on why that’s true.

You have EU distributors in Germany, France and/or Italy that are also distributing your devices in Switzerland…

Medical device manufacturers without distributors in Switzerland often (unknowingly) have coverage for the Swiss market through distributors in Germany, France and Italy. Non-Swiss distributors often serve parts of Switzerland partially due to geography (the Alps) but more commonly because of strong language, economic and cultural ties. Switzerland is landlocked by economic powerhouses: Germany to the north, France to the west and Italy to the south.

Many smaller non-EU manufacturers (and their EU distributors) are blissfully unaware of new Swiss requirements mentioned earlier. Here’s a common situation.

  • US-based medical device manufacturer ships devices to their distributor in Lyon, France.

  • The distributor serves southern France and western Switzerland, which includes French-speaking regions around Geneva and Lausanne

  • The manufacturer’s designated EU Authorized Representative is located in Germany

Because you are considered the legal manufacturer, this could present a real financial and legal headache if there were to be an incident with your devices in Switzerland.

If you are unsure whether your EU-based distributors are also selling in Switzerland, you need to find out right away. If so, you’ll need to appoint an importer and CH-REP to be in compliance with the Swiss MedDO ordinance. Fortunately, this is to do with MedEnvoy.

See How We Can Help You Comply with Swiss Requirements

MedEnvoy is a registered Swiss Authorized Representative and Importer with offices in Switzerland, US, The Netherlands and the UK. Let us help you comply with new Swiss MedDO requirements.

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