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EU Notified Bodies for Switzerland

Overview​

Switzerland has no Swiss-designated notified bodies for medical devices under the MedDO/IVDO framework. All conformity assessment procedures requiring notified body involvement must use EU-designated notified bodies. Manufacturers use EU-designated NBs (under EU MDR/IVDR) for all conformity assessment procedures requiring NB involvement. The EU NB certificate forms the basis for Swiss market access, subject to the MRA.

Practical Workflow​

  1. Engage an EU-designated NB with scope covering your device class (check NANDO)
  2. Complete conformity assessment under EU MDR/IVDR (Annex IX, X, or XI)
  3. Receive EU NB certificates (QMS certificate + EU type examination/design examination certificate where applicable)
  4. Issue Declaration of Conformity referencing MedDO compliance
  5. Register in DAPI (where required, depending on MRA status)

Under MRA Chapter 4, Swissmedic does not re-review the NB's technical documentation assessment. When MRA Chapter 4 is not fully operational, Swissmedic may conduct a full or selective technical documentation review.

MRA Impact​

MRA StatusEffect
MRA Chapter 4 operationalCE-marked devices generally access Swiss market without separate full registration (DAPI notification still required)
MRA Chapter 4 not fully operationalAll devices require DAPI registration regardless of CE status; EU NB certificate is the evidentiary basis

See MRA with EU — Current Status.

When MRA Chapter 4 is Not Fully Operational ​ If Chapter 4 is not operational, manufacturers must: submit the EU NB certificate (QMS and design/type examination certificates as applicable) along with the Swiss Declaration of Conformity; register the device in DAPI with complete technical documentation references; expect Swissmedic to conduct a full technical documentation assessment or selective review to verify compliance with MedDO; allow extended timelines for market access (typically 2–4 weeks beyond EU certificate issuance for initial DAPI review).

Official Sources​

Disclaimer

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