EU MDR technical documentation must satisfy Annex II (content) and Annex III (post-market). Use this checklist to validate completeness before engaging a Notified Body.
1) Device description and specifications
- Intended purpose, indications, contraindications, user profile, and environments.
- Classification rationale (Rule-based) and accessories/variants list.
- UDI strategy and labeling symbols aligned to EN ISO 15223-1.
- GSPR mapping table with evidence references.
2) Design and manufacturing information
- Design outputs, drawings, BOM, critical suppliers, and manufacturing flow.
- Software architecture, cybersecurity controls, SOUP list, and configuration management.
- Verification reports tied to design inputs; change control records for iterations.
3) Benefit-risk and risk management file
- ISO 14971 risk management plan, hazard analysis, and residual risk evaluation.
- Risk control measures with verification/validation proof.
- Usability and human factors evidence aligned to IEC 62366.
4) Product verification and validation
- Bench/functional testing with acceptance criteria and summary reports.
- Biocompatibility and sterilization (if applicable) or justification of non-applicability.
- Electrical safety/EMC (IEC 60601 series as applicable).
- Software verification/validation and cybersecurity tests.
- Packaging/transportation testing and shelf-life studies.
5) Clinical evaluation (CER)
- Clinical evaluation plan, PMCF plan (if needed), and state-of-the-art analysis.
- Clinical data appraisal, equivalence justification, and benefit-risk conclusions.
- Summary of safety and clinical performance (SSCP) where required.
6) PMS and PMCF (Annex III)
- PMS plan with data sources, indicators, vigilance, trend reporting.
- PMCF activities, protocols, and triggers for updates.
- CAPA linkage and management review inputs.
7) Declaration of conformity and QMS
- EU Declaration of Conformity with references to applied harmonized standards.
- QMS alignment with ISO 13485 and MDR Article 10 requirements.
- Economic operator roles and agreements (manufacturer, importer, distributor).
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