Does the EU Authorized Representative need access to my technical documentation?

## Does the EU Authorized Representative Need Access to My Technical Documentation? **Yes—this is a core obligation.** A fundamental requirement is that the EU AR must keep certain documentation available for competent authorities upon request, and cooperate with authorities. However, the exact mechanism (physical holding vs. contractual access) can vary. ### The Legal Requirement Article 11(3)(b) of MDR and IVDR states that the EU AR must **keep available for inspection by the competent authorities** the technical documentation, the EU declaration of conformity, and, if applicable, a copy of the relevant certificate. ### Two Approaches to Documentation Access EU AR providers handle this requirement in two main ways: #### Option 1: EU AR Holds the Technical Documentation The EU AR physically maintains the technical documentation and can provide it directly to competent authorities when requested. **Advantages:** - Faster response to competent authority requests - EU AR can verify documentation completeness - Lower operational burden on manufacturer - Better compliance assurance **Considerations:** - Higher cost (EU AR must maintain document management systems) - Requires ongoing document updates and version control - Manufacturer must provide documentation to EU AR #### Option 2: Contractual Access Clause The EU AR and manufacturer contractually agree that the **manufacturer will submit the documentation directly to competent authorities** upon request, with the EU AR ensuring this happens. **Advantages:** - Lower cost (manufacturer maintains documentation) - Manufacturer has direct control over documentation - More flexible for manufacturers with existing document systems **Considerations:** - Manufacturer must be able to respond quickly to requests - Higher operational burden on manufacturer - Requires strong coordination between manufacturer and EU AR ### What Technical Documentation Includes Technical documentation typically includes: - Device description and specifications - Intended purpose and indications - Risk management documentation - Clinical evaluation reports - Labeling and IFU - Manufacturing information - Quality system certificates - Conformity assessment documentation - UDI information - Post-market surveillance data ### Questions to Ask Your EU AR Provider 1. **"Do you hold the tech file, or do you rely on a contractual manufacturer submission clause?"** - Understand which model they use - Know what this means for your operations 2. **"What evidence do you need from us to be confident you can meet competent authority requests?"** - They should ask for documentation samples - They should verify your documentation is complete and accessible 3. **"What happens if we can't meet a competent authority request deadline?"** - Understand the escalation process - Know the consequences of non-compliance 4. **"What format do competent authorities require, and do you help with formatting?"** - Technical documentation must meet MDR/IVDR requirements - Some EU ARs provide formatting support ### This Clause is a Major Differentiator EU AR providers handle documentation very differently: #### Full Document-Control Workflows Some EU ARs: - Maintain complete technical files - Have document management systems - Provide ongoing document review and updates - Handle competent authority requests directly - **Higher cost, but lower risk** #### Contractual Access + Escalation Other EU ARs: - Rely on manufacturer to provide documentation - Use contractual clauses to ensure access - Escalate to manufacturer when requests come in - **Lower cost, but higher operational burden on manufacturer** ### Best Practices 1. **Know Your Model** - Understand whether your EU AR holds docs or relies on contractual clause 2. **Prepare Documentation** - Have technical files organized and accessible 3. **Test Response Time** - Practice responding to documentation requests 4. **Document the Process** - Create SOPs for handling competent authority requests 5. **Maintain Relationships** - Keep communication open with your EU AR about documentation status ### Practical Recommendation If you're a small manufacturer or have limited regulatory resources, consider an EU AR that offers full document-control workflows. The additional cost may be worth the reduced operational burden and lower compliance risk. If you have strong regulatory capabilities and well-organized documentation, a contractual access model may work well and be more cost-effective. ### Next Steps 1. Assess your documentation readiness and response capabilities 2. Evaluate EU AR providers based on their documentation handling model 3. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Compare providers offering different documentation service levels --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Regulation (EU) 2017/745 (MDR) - Article 11](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)