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MRA Status Updates

Overview​

The CH–EU MRA Chapter 4 operational status is a critical variable for every Swiss market access strategy for CE-marked devices. This page tracks MRA status developments.

Always verify current MRA status

The MRA status can change. Verify the current operational status with Swissmedic or SECO before making market access decisions.

Background​

See MRA with EU — Current Status for full background on what the MRA covers and its regulatory significance.

Where to Monitor MRA Status​

Practical Checklist — Regardless of MRA Status​

These obligations always apply:

  • CH REP appointed (if not established in Switzerland)
  • DAPI notification/registration completed
  • Swiss labelling (DE/FR/IT) in place
  • Vigilance reporting processes to Swissmedic eVigilance established
  • FSCA notification process to Swissmedic established

What changes with MRA status: whether CE-marked devices can rely on EU NB assessment (MRA operational) or whether additional Swiss technical review may be required (MRA not fully operational). Both notification and registration requirements in DAPI apply regardless of MRA status.

Disclaimer

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

Practical Checklist — Regardless of MRA Status​

"During periods when the MRA is suspended or not fully operational, CE-marked devices may require full Swiss technical dossier review and cannot rely solely on EU NB assessment. Check current MRA status before finalizing market access timelines."