One Stockholm-based partner for EU medical device EU Rep, Swiss CH-REP, and GPSR consumer product compliance. Select the pathway that matches your product type.
Mandatory EU Authorised Representative under MDR Article 11. EUDAMED registration, vigilance, and Competent Authority liaison for non-EU medtech manufacturers.
Medical device EU Rep →Swiss Authorised Representative for non-Swiss manufacturers. Swissmedic registration, MedDO labelling, and cross-border EU+CH compliance.
Swiss CH-REP services →EU Responsible Person for general consumer goods. E-commerce, Amazon EU, and DTC brands — product safety, labelling, and market surveillance contact.
GPSR consumer products →EU Rep (MDR Article 11): Mandatory for every non-EU medical device manufacturer selling in the European Union. Covers all 27 member states from a single Stockholm-based agreement. Includes EUDAMED actor registration, vigilance reporting, and Competent Authority liaison.
Swiss CH-REP (MedDO): Mandatory separately for Switzerland. Your EU Rep does not cover the Swiss market. Required for Swissmedic registration, MedDO labelling, and post-market obligations in Switzerland.
GPSR Responsible Person: Required for general consumer products sold in the EU (not medical devices). Covers product safety, labelling, and market surveillance contact for e-commerce and DTC brands.
Many US and UK manufacturers appoint NordMDR AB for EU Rep and CH-REP under coordinated agreements — one regulatory contact, two compliant pathways. Start with our EU MDR consulting review if you are unsure where to begin.