MDR Technical Documentation: Requirements and Practical Obstacles

The Technical Documentation (TD) of a medical device is not just a regulatory file used to obtain CE marking; it also reflects the manufacturer’s maturity in quality, clinical, and regulatory affairs.

Under Regulation (EU) 2017/745 (MDR), the TD must demonstrate that the product is safe, effective, and compliant. Yet every year, dozens of manufacturers fail—not because of a defective product, but due to a weak file.

The contents of the technical documentation are defined in Annexes II and III of the MDR. This article follows that structure while highlighting concrete blocking points observed in practice.

Critical Anatomy of a TD – What is Expected vs. What Goes Wrong

1. General Description of the Product

🔹 What the MDR requires The documentation must include full device identification (including basic UDI-DI, variants, and accessories), a detailed risk class justification (Annex VIII), intended use, mode of action, materials used, technical specifications, and references to previous generations and similar devices.

🔸 What Notified Bodies often find Classification justifications are often superficial, intended uses are inconsistent across documents, and contraindications are missing or incomplete.

✅ What makes the difference Provide a clear, coherent, and complete classification justification; ensure that the intended use is consistent across all documents (IFU, risk management, PMS, CER); show that the target patient groups were considered and that contraindications are explicit. A comparative analysis between the device and previous generations or similar products should support innovations.

2. Information Supplied by the Manufacturer

🔹 What the MDR requires The TD must include the EU Declaration of Conformity, labelling, Instructions for Use (IFU), implant card (if applicable), promotional materials, and the website URL where the IFU is available.

🔸 What Notified Bodies often find Incomplete declarations, inconsistencies between the SSCP, IFU, and marketing materials.

✅ What makes the difference All materials must be rigorously aligned. The basic UDI-DI must be correctly assigned. Essential information (intended use, indications, warnings) must be consistent across all channels.

3. Design and Manufacturing

🔹 What the MDR requires A detailed description of manufacturing processes, associated validations, production environments, critical suppliers and their certifications, and acceptance criteria for raw materials and components.

🔸 What Notified Bodies often find Missing or incomplete validations; lack of documented control over critical subcontractors.

✅ What makes the difference List critical suppliers clearly, include qualification evidence (audits, certificates), provide validation plans (IQ/OQ/PQ, cleaning, sterilization, packaging), and attach relevant reports. Show examples of incoming, in-process, and final quality controls.

4. General Safety and Performance Requirements (GSPR)

🔹 What the MDR requires Demonstrate compliance with Annex I requirements using a justification matrix, listing applicable standards and related evidence.

🔸 What Notified Bodies often find Generic GSPR tables, vague or unversioned evidence, unjustified non-applicabilities.

✅ What makes the difference Each requirement should be tied to a precise, dated, and traceable piece of evidence (report, standard, test). Justify all non-applicabilities with technical arguments.

5. Benefit-Risk Analysis and Risk Management

🔹 What the MDR requires Risk management must comply with ISO 14971, including a plan, analysis, report, and integration with safety requirements (Annex I, point 4).

🔸 What Notified Bodies often find Acceptance criteria are missing or poorly defined; residual risks are not properly assessed.

✅ What makes the difference Define acceptance criteria in the plan, assess each risk individually, and demonstrate risk control with evidence (tests, validations, PMS data).

6. Product Verification and Validation

🔹 What the MDR requires Expected evidence includes mechanical tests, electrical and EMC tests, biocompatibility (ISO 10993), sterilization, aging, performance, cybersecurity, software validation (ISO 62304), clinical evaluation, usability (IEC 62366-1), stability, and CMR/endocrine disruptor assessment.

🔸 What Notified Bodies often find Missing evaluator qualifications, partial packaging validations, poorly defined clinical criteria.

✅ What makes the difference Include expert qualifications (toxicology, biology…), apply ISO 11607 for packaging validation, provide a substantiated clinical evaluation, and document a complete usability analysis (plans, protocols, results, error analysis).

7. Post-Market Surveillance

🔹 What the MDR requires The manufacturer must provide a PMS plan, a PMCF plan (if applicable), a PSUR for Class IIa, IIb, III devices, and demonstrate risk feedback integration.

🔸 What Notified Bodies often find Overly generic plans, PSURs reduced to tables, poor integration of incidents into the system.

✅ What makes the difference PMS must be based on field data, PSURs should show exploitable trends, and PMS results should be reflected in the risk file, IFU, and clinical evaluations.

8. Special Case Devices: Additional Requirements

Depending on device type, additional elements may be required:

• Implants: MRI safety, patient card, long-term surveillance
• Systemically acting/absorbed substances: ADME data, local tolerance
• CMR or endocrine-disrupting substances: Justify presence, show no alternatives, document exposure
• Software: Full development file (ISO 62304) and cybersecurity documentation
• Connected devices: Compatibility and interoperability testing

All relevant content must be included in dedicated annexes where applicable.

Conclusion

A technical documentation is not a random file collection—it is a coherent system of evidence showing that the device is safe, compliant, and continuously monitored throughout its lifecycle.

This guide is not a rigid checklist: it is intended to help you build a clearer, more defensible file aligned with field expectations.

Want to go further?

Certeafiles offers:

• Targeted white audits of your technical file
• Practical MDR training (GSPR, CER, PMS…)
• Critical review or full build of your technical documentation

📧 Contact us for personalized support.