Swissmedic

Swiss medical device regulator; Switzerland is now a third country to the EU under MDR.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

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.

What this means in practice

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

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

Swissmedic·1European Commission·1IMDRF·1

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On this term

Category: Regulatory
Sources: 3
Updated: 5/5/2026

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Swiss medical device regulator; Switzerland is now a third country to the EU under MDR.

·Often overlooked when planning EU launches; missing CH-REP or labeling routinely blocks Swiss commercialization.
·Since the EU-Swiss Mutual Recognition Agreement was not updated for MDR, manufacturers need a Swiss Authorized Representative (CH-REP) and Swiss-specific labeling.

Remember this

Swiss medical device regulator; Switzerland is now a third country to the EU under MDR.

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