MDR Annex II and Annex III Technical Documentation Checklist

How to use this MDR checklist

Use the checklist to organize a readiness review. For each item, record the document name, version, owner, evidence location, review status and any open question. Do not treat a checked box as proof that the evidence is adequate.

Annex II: device description and specification

• Product or trade name and a general description of the device
• Intended purpose, intended users and intended patient population
• Basic UDI-DI and other identification details when applicable
• Principles of operation and mode of action
• Rationale for qualification as a medical device
• Risk class and justification for the classification rule applied
• Accessories, variants, configurations, software and components
• Previous generations and similar devices where relevant

Review for consistency across the intended purpose, labeling, risk management, clinical evaluation and verification evidence. A clear description at the front of the file reduces ambiguity throughout the rest of the assessment.

Annex II: information supplied, design and manufacturing

• Labels on the device and packaging in the languages required for target markets
• Instructions for use and other information supplied with the device
• Design stages, specifications, drawings, software architecture and design outputs
• Manufacturing processes, validation activities and monitoring
• Identification of all sites involved in design and manufacturing
• Supplier or subcontractor information where it is relevant to conformity

Annex II: General Safety and Performance Requirements

The documentation should identify the General Safety and Performance Requirements that apply, explain how conformity is demonstrated, identify the standards or other methods used, and point to the controlled evidence supporting each conclusion.

Annex II: benefit-risk, risk management and clinical evaluation

• Benefit-risk analysis and current risk-management documentation
• Hazard identification, risk-control measures and evaluation of residual risk
• Clinical evaluation plan, report and supporting clinical data
• Post-market clinical follow-up plan and report, or a justified position
• Traceability between claims, risks, clinical evidence and information supplied

These materials should work as one evidence chain. Reviewers commonly lose time when the risk file, clinical evaluation, labeling and post-market plan use different device scopes, claim language or version references.

Annex II: product verification and validation

• Pre-clinical and clinical data appropriate to the device
• Laboratory, engineering, simulated-use and animal testing where applicable
• Biocompatibility and physical or chemical characterization
• Electrical safety, electromagnetic compatibility and software verification
• Stability, transport, packaging and shelf-life evidence
• Sterilization validation and microbiological controls where applicable
• Test protocols, acceptance criteria, results, deviations and conclusions

The applicable evidence depends on the device. The review should confirm that test articles, configurations, versions and acceptance criteria match the device and claims being assessed.

Annex III: post-market surveillance documentation

• A post-market surveillance plan proportionate to the device and its risks
• Sources and methods for collecting complaints, incidents, trend data, literature and user feedback
• Methods for assessing collected information and identifying corrective or preventive action
• Indicators and threshold values used for continuous reassessment
• Links to vigilance, trend reporting, risk management and post-market clinical follow-up
• The applicable periodic safety update report or post-market surveillance report

Annex III should not read like a future promise disconnected from the rest of the file. It should show how post-market information will update risk management, clinical evaluation, labeling and corrective action.

Final readiness controls

1. Freeze a document index with stable identifiers and versions.
2. Confirm that cross-references resolve to the correct evidence.
3. Reconcile device names, models, intended purpose and claims across the file.
4. Document every not-applicable rationale.
5. Separate missing documents from questions about evidence adequacy.
6. Route regulatory, clinical and technical issues to qualified reviewers.
7. Preserve the approved submission set and the history of subsequent changes.

Frequently asked questions

Sources and further reading

• Regulation (EU) 2017/745 on medical devices — EUR-Lex
• MDCG-endorsed documents and medical-device guidance — European Commission