Swissmedic enforces the Swiss Medical Devices Ordinance (MedDO), which mirrors most of EU MDR. Since the EU-Swiss Mutual Recognition Agreement was not updated for MDR, manufacturers need a Swiss Authorized Representative (CH-REP) and Swiss-specific labeling. The IVD rules sit in a parallel ordinance, the In Vitro Diagnostic Medical Devices Ordinance (IvDO), which closely follows the IVDR. Swiss importers carry their own obligations, and Switzerland unilaterally recognizes CE certificates issued by EU notified bodies, so a separate Swiss conformity assessment is usually not needed.

Why it matters

Often overlooked when planning EU launches; missing CH-REP or labeling routinely blocks Swiss commercialization.

Common pitfalls

•A common pitfall is assuming that EU MDR compliance alone is sufficient for market access in Switzerland, neglecting the specific Swiss requirements.
•Manufacturers often overlook the need for a designated Swiss Authorized Representative (CH-REP) before placing devices on the Swiss market.
•Failing to implement Swiss-specific labeling requirements, such as language and symbol variations, can lead to market access delays.
•Confusion regarding the status of the EU-Switzerland Mutual Recognition Agreement (MRA) post-EU MDR implementation can result in non-compliance.

Sources

Swissmedic Medical Devices · Swissmedic
European Commission - Medical Devices · European Commission
IMDRF Documents · IMDRF

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