Do EU/EEA manufacturers also need a CH-REP to sell in Switzerland?

## Do EU/EEA Manufacturers Need a CH-REP? **Yes—EU/EEA manufacturers absolutely need a CH-REP to sell in Switzerland**, even though they may already have CE marking under EU MDR/IVDR. ### Why This Surprises People Many EU manufacturers assume that because: - Switzerland has similar regulations to the EU (MedDO aligns with MDR, IvDO aligns with IVDR) - They already have CE marking and an EU Authorized Representative - The regulatory frameworks are harmonized ...they don't need a separate Swiss representative. However, this is a common misconception. ### The Reality: Switzerland's Independent Market Access Requirements Switzerland treats **all manufacturers not established in Switzerland as "foreign"** for regulatory purposes, regardless of whether they're from the EU/EEA or elsewhere. According to Swissmedic's economic-operators guidance, the CH-REP requirement applies to manufacturers established in the EU/EEA just as it does to manufacturers from other countries. ### What This Means for EU Manufacturers For EU manufacturers, entering the Swiss market becomes: 1. **A packaging and labeling exercise** - You'll need to add CH-REP information to your labels, packaging, and IFU 2. **A contract and mandate exercise** - You must establish a written mandate with a Swiss-based CH-REP 3. **A registration exercise** - The CH-REP (and potentially you as importer) must register for CHRN 4. **A vigilance coordination exercise** - You'll need to ensure Swiss-specific reporting flows are established **Your CE conformity work remains central** - you don't need to re-certify your devices, but you must establish the Swiss economic-operator chain. ### Key Distinction - **EU-REP**: Required for EU/EEA market access (handles EU MDR/IVDR compliance) - **CH-REP**: Required for Swiss market access (handles Swiss MedDO/IvDO compliance) These are separate roles that cannot be combined, even though the underlying regulations are similar. ### Next Steps 1. **[Compare Swiss CH-REP providers & request quotes](https://cruxi.ai/regulatory-directories/ch_rep)** - Use our directory to find and compare qualified CH-REP providers --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Swissmedic - Economic Operators Guidance](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)