Why Technical Documentation Matters
Technical documentation (often called the technical file) is the evidence regulators and notified bodies review to confirm that a device is safe, effective, and compliant. Missing or incomplete files are among the most common reasons for delayed MDR approvals.
Core Components of Technical Documentation
1. Device Description and Specifications
- Define intended purpose, design, and operating principles.
- Include variants, accessories, and compatibility information.
2. Risk Management File
- Based on ISO 14971.
- Identify hazards, risk evaluations, and mitigation measures.
- Document residual risks and justifications.
3. Clinical Evaluation
- Provide data on safety and performance.
- Include clinical trials, literature reviews, and post-market clinical follow-up (PMCF) plans.
4. Design and Manufacturing Information
- Details on design process, materials used, and production methods.
- Quality control and validation procedures.
5. Labeling and IFU (Instructions for Use)
- Clear, compliant labeling in line with MDR requirements.
- Multilingual IFUs where applicable.
6. Post-Market Surveillance (PMS) Plan
- Outline how the device will be monitored after launch.
- Link PMS to risk management and CAPA processes.
Best Practices for Building Documentation
- Start Early: Don’t wait until the final stages of development.
- Keep It Organized: Use a digital document management system.
- Cross-Functional Approach: Involve engineering, clinical, and regulatory teams.
- Update Regularly: Documentation is a living file, not a one-time task.
- Audit-Ready Mindset: Always prepare as if a notified body will review tomorrow.
Common Mistakes to Avoid
- Incomplete or inconsistent data between sections.
- Over-reliance on outdated clinical literature.
- Failing to update documentation after design changes.
- Lack of traceability between design, risks, and clinical evidence.
Conclusion
Preparing technical documentation for MDR approval can seem like a heavy task, but it’s also an opportunity to demonstrate the quality and reliability of your device.
By structuring documents carefully, involving the right experts, and maintaining a proactive approach, companies can achieve smoother approvals and long-term compliance in the EU market.
