What must be in the written CH-REP mandate (agreement) with the manufacturer?

## What Must Be in the Written CH-REP Mandate? Swissmedic explicitly requires a **written mandate** between the manufacturer and the CH-REP. This isn't optional—it's a regulatory requirement. To make your mandate "operational" and avoid delays, include these essential elements: ### 1. **Scope Definition** Clearly define which devices, brands, and "generic device group(s)" are covered. Avoid vague "all products" wording unless it's truly accurate. **Include:** - Specific device families or product lines - Intended purposes and indications for use - Risk classifications (Class I, IIa, IIb, III for medical devices; Class A, B, C, D for IVDs) - UDI information if applicable - Any exclusions or limitations ### 2. **Regulatory Handoffs** Define the operational workflow for regulatory activities: - **Who drafts** vigilance submissions and safety reports? - **Who reviews** and approves submissions before sending to Swissmedic? - **Who signs** official communications with Swissmedic? - **Response timelines** - How fast must you respond to Swissmedic requests? - **Escalation procedures** - What happens if there are disagreements or urgent issues? ### 3. **Documentation Access** Specify how technical documentation will be handled: - **Option A**: CH-REP holds the technical file - Where is it stored? - How is it kept up to date? - What format is required? - **Option B**: Manufacturer commits to submit directly to Swissmedic within 7 days - What triggers the 7-day clock? - What format must documentation be in? - What happens if you can't meet the 7-day deadline? - What evidence does the CH-REP need to be confident you can meet this requirement? This clause is a **major differentiator** between CH-REP providers—some run full document-control workflows, while others operate on contractual access and escalation. ### 4. **Change Control Procedures** Establish how you'll handle changes: - **Labeling changes** - How are UDI, IFU, or packaging updates communicated? - **Device changes** - How are design or manufacturing changes reported? - **Distribution changes** - How are new importers or distribution channels notified? - **Regulatory changes** - How are updates to Swissmedic requirements handled? ### 5. **Termination and Transition** Define what happens if you switch CH-REPs: - **Market presence** - Can devices remain on the market during transition? - **Records retention** - Who holds historical records and for how long? - **Open vigilance cases** - How are ongoing investigations transferred? - **Notification requirements** - Who notifies Swissmedic of the change? - **Transition timeline** - How long does the handover take? ### 6. **Financial and Liability Terms** While not directly regulatory, include: - Fee structure and payment terms - Liability allocation for regulatory non-compliance - Insurance requirements - Dispute resolution procedures ### Best Practices 1. **Be Specific** - Vague mandates lead to operational confusion and regulatory risk 2. **Define Timelines** - Set clear expectations for response times and deliverables 3. **Document Workflows** - Create process maps for key activities (vigilance, documentation requests) 4. **Regular Review** - Update the mandate as your product portfolio or operations change 5. **Legal Review** - Have your legal team review the mandate before signing ### Red Flags to Avoid - ❌ Mandates that say "all products" without defining what that means - ❌ Missing documentation access procedures - ❌ Unclear vigilance reporting responsibilities - ❌ No termination or transition procedures - ❌ Vague response time commitments ### 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 - CH-REP Obligations Sheet](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)