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MRA with EU — Current Status

Overview​

The Mutual Recognition Agreement (MRA) between Switzerland and the European Union includes Chapter 4, which covers medical devices and in vitro diagnostics. When MRA Chapter 4 is operational, EU-designated notified bodies are recognised in Switzerland and CE-marked devices that comply with EU MDR/IVDR can generally access the Swiss market without separate Swissmedic technical re-evaluation.

What the MRA Covers​

When fully operational, MRA Chapter 4 allows:

  • CE certificates issued by EU-designated NBs to be recognised for Swiss market access
  • Swiss NB (when designated — currently none) certificates to be recognised in the EU
  • Simplified conformity assessment and market access procedures for CE-marked devices
  • Reduced duplicative assessment between Swiss and EU regulators

Current Operational Status​

MRA-sensitive content

The operational status of the CH–EU MRA Chapter 4 is subject to change depending on the broader state of CH–EU bilateral agreements. Always verify the current status directly with Swissmedic or the Swiss State Secretariat for Economic Affairs (SECO) before planning a Swiss market access strategy.

The MRA Chapter 4 has had a complex history tied to the broader CH–EU bilateral relations framework. The practical impact on medical device market access varies depending on the current agreement status:

  • If MRA Chapter 4 is fully operational: CE-marked devices (compliant with EU MDR/IVDR) can access the Swiss market with a simplified DAPI notification; full separate registration is generally not required
  • If MRA Chapter 4 is not fully operational: Full DAPI registration is required for all devices regardless of CE marking status; EU NB certificates are still used as the evidentiary basis but the registration process is fully required

Practical Implications for Manufacturers​

Regardless of MRA status, manufacturers placing devices on the Swiss market must:

  1. Ensure the device complies with MedDO/IVDO requirements (which mirror EU MDR/IVDR)
  2. Appoint a CH REP (if not established in Switzerland)
  3. Complete DAPI registration or notification
  4. Comply with Swiss labelling requirements (DE/FR/IT)
  5. Report serious incidents to Swissmedic via eVigilance

The MRA affects primarily the extent of DAPI registration requirements and whether Swiss re-evaluation of the NB technical assessment is required.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.