EU MDR Technical Documentation Readiness Assessment
Notified bodies and competent authorities expect technical documentation structured around Annexes II and III of the EU MDR. This ten question self-assessment shows where your file is strong and where evidence is thin.
1. Device description and specification (Annex II section 1)
Intended purpose, variants, accessories, principles of operation and configurations.
2. Information supplied by the manufacturer (labels and instructions for use)
3. Design and manufacturing information (section 3)
Manufacturing processes, validation, sites and suppliers.
4. General safety and performance requirements (GSPR) checklist
Each applicable requirement with the method of demonstrating conformity.
5. Benefit-risk analysis and risk management file
6. Verification and validation evidence (bench, biocompatibility, software, electrical, sterilization, shelf life)
7. Clinical evaluation report and clinical evidence plan
8. Post-market surveillance plan, PMS report or PSUR (Annex III)
9. Document control and traceability of the technical file itself
10. UDI, registration and declaration of conformity readiness
How to use it
Answer each question for one device family, with the regulatory lead and design owner in the room. Choose the option you can prove today from the controlled documents, not the one you expect to complete next month. The score and band summarize readiness and the recommendations highlight where to start. Export the result and repeat it quarterly while the file is being built.
- One device family per assessment
- Score what exists in controlled form
- Repeat quarterly and compare
What Annex II and Annex III expect
Annex II describes the technical documentation: device description and specification, information supplied with the device, design and manufacturing information, the general safety and performance requirements checklist, benefit-risk and risk management, and product verification and validation including clinical evaluation. Annex III covers the technical documentation on post-market surveillance. The questions follow this structure so results map to sections you will submit.
Reading your result
A low score on the GSPR or verification questions is the most serious because those sections carry the proof of conformity. A low score on document control matters more than it seems, since an unindexed file is hard to review and prone to inconsistent versions. Clinical evaluation is usually the longest lead item, so start early if it scores low.
Common mistakes
Frequent problems include GSPR tables without references, risk files not updated after design changes, labeling that differs between the technical file and the packaging, clinical evaluation based on equivalence that cannot be justified, and PMS plans that exist but do not feed back into risk management. Keep the file connected to change control so every design change prompts a review.
Frequently Asked Questions
Is this a conformity assessment?
No. It is a self-check to find gaps. Conformity assessment is performed according to the MDR route for your class, often with a notified body.
Does it apply to legacy devices under transition?
The structure applies, but transitional provisions and timelines have their own conditions. Check current EU transition rules for your certificates.
Why is document control scored?
Reviewers need a consistent, versioned file. If the file cannot be indexed and shown to be current, even good content is hard to defend during review.
Can I use it for non-EU markets?
Much of the content overlaps with other markets, but FDA, Health Canada and others have their own formats. Use it as a starting point and map to local requirements.
If your technical documentation depends on ERP data for suppliers, lots and changes, Netray can discuss ways to keep those references accurate.
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Quality & InspectionIEC 62304 Software Lifecycle Documentation Checklist
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Compliance & ContractsMedical Device Standards Reference Table (ISO, IEC, ASTM)
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