Checklist for Writing Technical Documentation for EU MDR Compliance

1. Start with a Comprehensive GSPR Checklist : Ensure all General Safety and Performance Requirements (GSPR) are addressed.
2. Use a Clear and Intuitive Structure : Follow guidance from your Notified Body (e.g., GMED, BSI, TUV) for structuring your documentation.
3. Include a Summary Document: Provide a summary to help reviewers quickly understand the documentation.
4. Regularly Update Documentation: Keep the documentation current, reflecting any changes to the device's status.
5. Use a Verification and Validation (V&V) Matrix: Implement a V&V matrix to organize and present all test results effectively.
6. Maintain Traceability: Ensure traceability from User Requirements Specifications (URS) to Functional Requirements Specifications (FRS).
7. Cross-reference Documents :Utilize hyperlinks to facilitate navigation between documents.
8. Write in Simple, Clear Language: Ensure the documentation is accessible and easy to understand.
9. Provide Objective Evidence: Back all claims with objective, verifiable evidence.
10. Use Clear, Searchable Electronic Formats: Ensure all documents are in a searchable electronic format.
11. Document Design and Manufacturing Processes: Include detailed flowcharts to illustrate the design and manufacturing processes.
12. Think of Documentation as an Ecosystem: Understand that the documentation should be dynamic and interconnected, avoiding contradictions.
13. Maintain a Coherent Ecosystem: Ensure coherence and consistency across all documents and reports.

Additional Key Points:

1. Follow Annexes II and III of the MDR :Structure your documentation in accordance with these annexes.
2. Include Detailed Device Description :Provide a comprehensive description of the device, its intended use, and specifications.
3. Maintain a Risk Management File :Include a risk management plan, analysis, and report.
4. Document Usability Testing :Create and include a usability engineering file.
5. Document Cybersecurity Measures: For devices with cybersecurity concerns, include detailed cybersecurity documentation.
6. Develop Clinical Evaluation Plan (CEP) and Report (CER) :Ensure you have a comprehensive CEP and CER.
7. Create a PMS/PMCF Plan :Develop a Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plan before submission.
8. Provide Labels and IFU: Include labels and Instructions for Use (IFU) in all relevant languages.
9. Ensure PRRC Oversight :Have a Person Responsible for Regulatory Compliance (PRRC) oversee the documentation.
10. Include Confidentiality Agreements: If using third-party representatives, include necessary confidentiality agreements.
11. Address Residual Risks :Document residual risks in both the risk management and clinical evaluation reports.
12. List Critical Suppliers and Subcontractors :Include a detailed list of all critical suppliers and subcontractors.
13. Include a Declaration of Conformity :Ensure a declaration of conformity is included as per Annex IV.