Switzerland’s New Regulations on CE-Marked Medical Devices

  • Switzerland’s New Regulations on CE-Marked Medical Devices

Swiss Trade Relations with the European Union

The European Union is an economic and political union of 27 countries. It operates an internal market which allows free movement of goods, capital, services and people between member states. Switzerland is not and has never been an EU member state.

Switzerland has associated with the EU through a series of bilateral treaties and agreements, allowing them to participate in the EU’s single market, without ever joining as a member state. The agreement facilitating trade of CE-marked products between the EU and Switzerland known as the Mutual Recognition Agreement (MRA), ceased to apply for medical devices after the application of the EU’s new Medical Device Regulation (MDR) on May 26, 2021.

Without a renewed MRA that includes CE-marked medical devices under MDR, Switzerland has now become a “third country” like the UK after Brexit. As a result, Switzerland has introduced new regulations on all imported CE-marked medical devices.

Switzerland’s new regulations are requiring the appointment of a local Swiss Authorized Representative and Swiss Importer for all CE-marked medical devices sold on the Swiss market. The appointed Swiss Authorized Representative or “CH REP” and the Swiss “Importer” must also be indicated by a label on the medical device packaging.

Deadlines for including the “CH REP” and Swiss “Importer” labels on CE-marked medical devices being imported into Switzerland are quickly approaching or have already passed. Some of Merit’s OEM customers are purchasing Class IIb/III medical devices with the already passed deadline of December 31, 2021. Most OEM customers purchase Class IIa/IIb Non-Implantable medical devices with the deadline of March 31, 2022. Here are the various deadlines based on medical device classification.

  • Class IIb/III + Active Implantable: December 31, 2021
  • Class IIa/IIb Non-Implantable: March 31, 2022
  • Class I + System/Procedure Packs: July 31, 2022

Importing Merit’s Products Into Switzerland

Merit is asking all OEM customers who import sterile CE-marked medical devices, legally manufactured by Merit, into Switzerland to take immediate action towards compliance with these new regulations. The following information is provided by Merit to assist our OEM customers in their actions towards reaching compliance. Merit suggests visiting the Swissmedic website for the official description and requirements of these new regulations.

Starting January 1, 2022, all Class III/IIb + Active Implantable sterile CE-marked medical devices imported into Switzerland need to include new label elements indicating the Swiss Authorized Representative and the Swiss Importer. Merit’s OEM customers importing sterile CE-marked products legally manufactured by Merit will to need to apply a secondary label containing Merit’s appointed CH REP, as well as the customer specific Swiss Importer information.

CH REP Label

Merit has appointed EUMEDIQ to be Merit’s local Swiss Authorized Representative. The name and address of the authorized representative’s registered place of business must be included, with the CH REP symbol on all CE-marked products being imported into Switzerland. Products legally manufactured by Merit must include the following information about the Merit appointed Swiss Authorized Representative next to the CH REP symbol.

EUMEDIQ AG
Gragenauweg 8
CH-6300 Zug,
Switzerland
www.eumediq.eu

Sterile CE-marked products, legally manufactured by Merit, must have a secondary label applied to them by the customer, before the customer imports the product into Switzerland. This label must contain the CH REP symbol and the name and address of Merit’s appointed Authorized Representative. The CH REP label cannot be placed over any existing product label from the manufacturer.

Here’s a link to the Swissmedic website to download the CH REP symbol in various file formats.

Swiss Importer Label

The new regulations also require a Swiss Importer label on all Class III/IIb + Active Implantable medical devices starting January 1, 2022. The Swiss importer information will be specific to the customer’s distribution arrangements for Switzerland and will differ from the Swiss Importer information Merit will be using.

Customers purchasing sterile CE-marked products, legally manufactured by Merit, will be responsible for applying a secondary label indicating the customer’s Swiss Importer information before the customer imports the product into Switzerland.

Distribution Agreements

New distribution agreements will be required for all Merit OEM customers purchasing sterile CE-marked products legally manufactured by Merit that have distribution in Switzerland. OEM customers with already established distribution agreements will need to have them amended to include compliance requirements to these new regulations.

If your organization has purchased Merit product intending to import into Switzerland, Merit is asking these customers to please submit their contact information with the form below. Once your contact information has been submitted, your Merit OEM representative will schedule a meeting to discuss your specific requirements and begin the process of establishing or amending a distribution agreement.

Merit is looking forward to working with our OEM customers, that might need assistance with these recent changes in Switzerland’s regulatory requirements.

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