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Swiss Authorised Representative

… and why a Swiss REP is required.

Medical devices (MD)

From 26 May 2021, it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative. This is a result of the Mutual Recognition Agreement on medical devices, between Switzerland & the European Union, not being updated with the MDR. This caused Switzerland to become a third country and ended the mutual recognition. The same is expected to happen from 26 May 2022.

At Obelis, we …

  • assume the role of Swiss Authorized Representative
  • ensure technical documentations have been drawn up
  • keep a copy of technical documentations readily available for inspection
  • cooperate and Provide SwissMedic all information upon request
  • inform the manufacturer of complaints and incidents
  • perform actor registration via SwissMedic
  • register devices to SwissMedic
  • provide ongoing regulatory news and updates

Swiss law has clearly defined the role and tasks of a Swiss Authorised Representative, where professionalism and qualifications need to be at the same level of those under the EU MDR. This means that it is highly recommended to designate a professional agency as CH Authorised Representative.

Non-Swiss manufacturers should designate a CH Authorised Representative at the latest:

  • By 31 of December 2021 for class III devices, class IIb implantable devices, and all active implantable devices.
  • By 31 March 2022 for non-implantable class IIb devices and class IIa devices.
  • By 31 July 2022 for class I devices, systems and procedure packs.

Economic operators based in Switzerland  – i.e., manufacturers, importers, authorised representatives, persons who assemble systems and treatment units – need to register to Swissmedic to obtain Swiss Single Registration Number (CHRN), which will serve as the identification number in diverse contexts and processes.

  • Within 3 months following the placing of a device on the Swiss market.
  • By 26 November 2021 for companies who have already placed products on the market before 26 May 2021.

In-vitro medical devices (IVD)

For the moment, the Medical Devices Ordinance of 17 October 2001 – IVDD applies to in vitro diagnostic medical devices on the Swiss market until a new law is published.

There is no need for additional labelling nor notification to Swissmedic of IVDs that were previously notified to an EU/EAA Competent Authority and feature a person that placed them on the EU/EEA market.

Cosmetics (COS)

For the moment, EU Cosmetics Regulation should be followed to enter the Swiss market. Contact us for further details, or find more information here.

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