Selling in Europe used to be so simple. As recently as May 2021, CE Marking granted you unfettered access to all European Union countries, plus Norway, Iceland, Lichtenstein and Switzerland. Alas, things became a bit more complicated after Brexit took hold and Swiss regulators subsequently got into a tussle with their EU counterparts. Going forward, if you want access to the UK and Swiss markets, you’ll have to jump through some extra hoops.
Swissmedic Now Requires Manufacturers to Appoint an Authorized Representative Based in Switzerland…
If your company does not have a registered subsidiary in the EU, you probably already have an EU-based Authorized Representative (EAR). And even If your company IS located in the EU, you’re about to need one. Why? The EU and Switzerland (not part of the EU) have always ensured the smooth flow of goods across borders using Mutual Recognition Agreements (MRA). In the case of medical devices, there was an MRA in place that allowed manufacturers from European countries and Switzerland to sell across borders without having to meet some of the other rules that would normally apply to “third-countries.”
Swiss and EU legislators could not agree over certain key issues not directly related to medical devices and the talks between them were abrogated. Unfortunately, no agreement was reached before the EU MDR went into effect in May 2021. Thus, when it comes to medical devices Switzerland is (for the time being) much like the UK. With no MRA in place, even EU-based manufacturers will now be required to register their company and devices in Switzerland and appoint a Swiss Authorized Representative (CH-REP). However, there is some time (depending on when you read this) to appoint a CH-REP:
Class IIb, Class III and active implantable devices: Swiss AR required by December 31, 2021
Class IIa, Class IIb non-implantable devices: Swiss AR required by March 31, 2022
Class I and System/Procedure Packs: Swiss AR required by July 31, 2022
As it can take 4-6 months to modify labeling and review/sign contracts, don’t wait until the 11th hour. The good news is that the Swiss Medical Device Ordinance (MedDO) mostly emulates the EU MDR so if you are exporting there and meet the MDD or MDR requirements, you’ll be able to sell in Switzerland provided you appoint a Swiss AR, and meet the requirements.
Yes, You’ll Also Need to Appoint an Importer Based in Switzerland
As they say in TV infomercials, “But wait, there’s more!” In addition to appointing a Switzerland AR, manufacturers must also appoint an importer. This Swiss requirement emulates Article 13 of the EU MDR and IVDR. You are encouraged to read more about the role and responsibilities of the Swiss importer.
Your Swiss importer plays an important role in your compliance with the Swiss Medical Devices Ordinance (MedDO). Their responsibilities are focused on compliance rather than logistics. Shown below are the general legal obligations of the Swiss Importer:
Verify that a Declaration of Conformity has been drawn up
Device is labeled according to MedDO requirements and accompanied by the required Instructions For Use (IFU)
Verify that a Unique Device Identification (UDI) has been assigned
Device labeling shows the importer’s name, place of business and address
Keep the manufacturer, distributors and CH-REP informed about complaints, field actions, recalls and product withdrawals and maintain a legally mandated Register of Help to ensure that non-compliant products are not placed on the market preventing costly remedial field actions
Inform Swissmedic, the manufacturer and CH-REP if the importer believes the device does not comply with MedDO
Check that storage and transportation conditions are suitable for the products
Maintain a copy of Declaration of Conformity and relevant certificates
Cooperate with Swissmedic as required
Because your Swiss importer must be identified on certain defined locations but separately from your Swiss CH-REP, it’s a good idea to appoint an independent entity to perform this role rather than a distributor.
Registering Medical Devices in Switzerland
With no MRA in place with the EU, Swissmedic has been cut off from Competent Authority access to the EU's new EUDAMED medical device database. As such the Swiss now have to build their own database and that means all manufacturers are required to register later this year and obtain a Swiss Single Registration Number (CHRN). This is much like the Single Registration Number (SRN) required in the EU and will be used to track products in Switzerland. As of August 2021, registration is not yet possible on the Swissmedic website but is expected later in 2021.
See How MedEnvoy Can Help You Comply with New Swissmedic 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.