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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​

Important: The operational status of the CH–EU MRA Chapter 4 is subject to change and depends on the broader CH–EU bilateral relations framework. Before planning any Swiss market access strategy, always verify the current MRA Chapter 4 operational status directly with Swissmedic or the Swiss State Secretariat for Economic Affairs (SECO).

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.

What the MRA Covers​

DAPI (Device Application Process Information)​

DAPI is Swissmedic's registration and notification system for medical devices and IVDs. The extent to which manufacturers must use the DAPI system depends on MRA Chapter 4 operational status:

  • DAPI notification (simplified): When MRA Chapter 4 is fully operational, manufacturers of CE-marked devices typically submit a notification via DAPI rather than a full registration dossier.
  • DAPI registration (full): When MRA Chapter 4 is not fully operational or for non-CE-marked devices, a complete registration including technical documentation and conformity assessment evidence is required.

Both processes require appointment of a Swiss Authorised Representative (CH REP) and payment of registration fees.