Do procedure packs need one CH-REP or many? Swissmedic guidance on CH-REP requirements for procedure packs

## CH-REP Requirements for Procedure Packs: Swissmedic Clarifies Swissmedic has finally published guidance that resolves a long-debated question about CH-REP obligations for procedure packs. This clarification is particularly important because Switzerland no longer has an updated Mutual Recognition Agreement (MRA) with the EU, creating regulatory grey zones that require explicit guidance. ### The Question When assembling a procedure pack for the Swiss market, manufacturers have been uncertain about CH-REP requirements: - **Does each individual device component need its own CH-REP?** - **Or is one CH-REP sufficient for the entire procedure pack?** ### Swissmedic's Clear Answer According to the new Swissmedic guidance: ✅ **Every individual component device requires its own CH-REP** ✅ **Plus, if the procedure pack is assembled outside Switzerland, the pack itself also requires a CH-REP** ### Why This Matters Since Switzerland no longer has an updated MRA with the EU, the MedDO (Swiss Medical Devices Ordinance) references the MDR (Medical Device Regulation) but without mutual recognition and alignment. This creates regulatory gaps and interpretation challenges. **Key implications:** 1. **Component-level CH-REP**: Each medical device that goes into your procedure pack must have its own Swiss Authorized Representative, even if they're from the same manufacturer. 2. **Pack-level CH-REP**: If you're assembling the procedure pack outside Switzerland (e.g., in the EU or elsewhere), the assembled pack itself requires an additional CH-REP. 3. **Dual representation**: This means procedure pack assemblers may need multiple CH-REP relationships: - One CH-REP for each component device (or multiple devices if one CH-REP represents multiple components) - One CH-REP for the assembled pack itself (if assembled outside Switzerland) ### Practical Example **Scenario**: You're assembling a surgical procedure pack containing: - Device A (surgical instrument) - Device B (surgical drape) - Device C (surgical gown) **CH-REP Requirements:** - Device A needs a CH-REP - Device B needs a CH-REP - Device C needs a CH-REP - If assembled outside Switzerland, the complete procedure pack also needs a CH-REP **Note**: The same CH-REP provider can represent multiple components and/or the pack, but each requires explicit mandate coverage. ### Regulatory Context The MedDO references the EU MDR, but without the MRA framework, Swissmedic has had to provide explicit guidance on areas where interpretation was unclear. Procedure pack CH-REP requirements were one such grey zone that has now been clarified. ### Compliance Considerations When planning your procedure pack strategy for Switzerland: 1. **Identify all component devices** and verify each has CH-REP coverage 2. **Determine assembly location** - if outside Switzerland, plan for pack-level CH-REP 3. **Coordinate CH-REP mandates** - ensure all required CH-REP relationships are in place before market entry 4. **Documentation requirements** - each CH-REP mandate must be properly documented per Swissmedic requirements ### Next Steps 1. Review your procedure pack components and verify CH-REP coverage for each 2. Confirm your assembly location and determine if pack-level CH-REP is required 3. Establish CH-REP mandates for any missing coverage 4. **[Compare Swiss CH-REP providers & request quotes](https://cruxi.ai/regulatory-directories/ch_rep)** - Use our directory to find qualified CH-REP providers who can handle both component and pack-level representation --- *Written by **Beat Keller**, Regulatory and Quality Expert. [Connect on LinkedIn](https://www.linkedin.com/in/beat-keller) for regulatory guidance.* ### Official Sources: - [Swissmedic - Economic Operators](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html) - [Swissmedic - Procedure Pack Guidance](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)