Since when has the CH-REP existed?

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Swiss Authorized Representative for Medical Devices (CH-REP)

The Swiss Authorized Representative (CH-REP) is a legally required entity for manufacturers outside Switzerland who wish to market their medical devices in the Swiss market. The CH-REP role was established with the introduction of the revised Medical Devices Act (MPG) and the Medical Devices Ordinance (MedDO) to align Swiss legislation with the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).

Timeline of CH-REP and CH-Importer Introduction

  • May 26, 2021: The revised Medical Devices Act (MPG) and MedDO come into force.

  • December 31, 2021: The Mutual Recognition Agreement (MRA) between Switzerland and the EU for medical devices expires.

Why is a CH-REP Necessary? With the expiration of the MRA, the previous simplifications for the import and distribution of medical devices from the EU to Switzerland ceased. Manufacturers outside Switzerland who wish to continue offering their products in the Swiss market are now required to designate a CH-REP. This representative:

  • Ensures compliance with regulatory requirements,
  • Acts as a point of contact for Swiss authorities,
  • Is responsible for communication on safety-related matters.


Role of the CH-Importer In addition to the CH-REP, the CH-Importer plays a crucial role in the distribution of medical devices in Switzerland.

  • The CH-Importer is responsible for the physical importation of the products.
  • They can be a legal or natural person based in Switzerland.
  • They must ensure that imported products comply with Swiss regulations.

Impact on Manufacturers and Importers

  • Non-Swiss manufacturers must appoint a CH-REP to continue marketing their medical devices in Switzerland.
  • Companies from the EU, which previously benefited from mutual recognition of conformity assessments, now need to designate a CH-REP or CH-Importer.

  • Without such representation, legal distribution in Switzerland is no longer possible.

Conclusion

The introduction of the CH-REP was a direct result of the revised Swiss medical device legislation and the expiration of the MRA with the EU. Since May 26, 2021, appointing a CH-REP has been mandatory for manufacturers based outside Switzerland. Without this entity, the legal sale of medical devices in Switzerland is no longer feasible.

Sources


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