Impact of the MRA Expiry

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Agreement Switzerland - EU









Impact of the MRA Expiry

What does MRA mean? 

It stands for Mutual Recognition Agreement which was the agreement between Switzerland and Europe concerning medical devices

Need for a CH-REP

Companies from the EU that wish to sell medical devices in Switzerland must enter into a contract with a CH-REP (Swiss Authorized Representative) and appoint one if they do not have a legal entity in Switzerland.

  • The CH-REP is responsible for ensuring compliance with Swiss regulations and acts as a point of contact for authorities (e.g., Swissmedic).
  • The CH-REP is registered with Swiss authorities, receives a CHRN (Swiss Registration Number), and records the mandates assigned to them.

  • The manufacturer must display the CHRN and related data on the product, similar to the EU-REP requirements.

Need for a CH-Importer

With the expiry of the MRA, medical devices imported into Switzerland must comply with Swiss regulations. Therefore, a CH-Importer is necessary to ensure that the imported products meet the regulatory requirements of the MedDO.

The CH-Importer is responsible for:

  • Ensuring compliance: Verifying that products meet Swiss regulatory requirements and labeling obligations.
  • Traceability: Documenting imported products and ensuring potential recalls in case of safety issues.

  • Collaboration with authorities: Assisting in market surveillance measures and reporting safety incidents.
  • Coordination with the CH-REP: Ensuring regulatory compliance and communication with the responsible CH-REP.

Changes in Conformity Assessment

With the expiry of the MRA, companies that wish to distribute their products in Switzerland must undergo a separate conformity assessment by a Swiss-recognized body.

  • Previously, the MRA allowed mutual recognition of conformity assessments between Switzerland and the EU, requiring companies to undergo only one evaluation.

Delays and Additional Costs

Companies must anticipate additional administrative efforts and costs, as they now need to comply with both EU conformity assessments and Swiss requirements.

  • Market entry delays may occur due to additional documentation and certification processes.

Changes in Market Surveillance

Switzerland can now independently enforce its own requirements for the market surveillance of medical devices, which may lead to increased control and monitoring of medical devices in the country.

Sources

The expiry of the MRA and the requirement for a CH-REP and a CH-Importer have led to increased administrative burdens for companies selling their products in Switzerland. An independent regulatory framework has become necessary, affecting both conformity assessments and market surveillance.


❓Are you a non-Swiss manufacturer or distributor of medical devices or in-vitro diagnostics looking to enter the Swiss market? Contact us today!


Location: Zug, Schweiz

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