EU MDR Technical Documentation templates for Software as a Medical Device (SaMD)
EU MDR in a Box provides a complete set of EU MDR Technical Documentation templates designed to help digital health teams prepare documentation in line with the Medical Device Regulation (EU) 2017/745.
All documents are provided in editable Word and PDF format and are structured as fill-in-the-blank templates with embedded questions and guidance notes explaining what is expected and how to tailor each section to your specific product. EU MDR in a box does not include Quality Management System that is also required for certification.
What’s Included
EU MDR Technical Documentation Structure
- Technical Documentation Overview (Annex II & III)
- Device Description and Specification template
- Intended Purpose and Indications template
- Classification and conformity assessment rationale
- General Safety and Performance Requirements (GSPR) checklist
Device & Software Description
- Device Description template
- Software Description and Intended Purpose
- System architecture and software overview
- Operating environment and interfaces
- Intended user and use environment description
EU MDR Risk Management & Safety
- Risk Management Plan
- Hazard Identification and Risk Analysis
- Risk Control Measures
- Residual Risk Evaluation
- Risk Management Report
(Aligned with ISO 14971 and MDR safety expectations)
Software Documentation (EU MDR Technical Dossier Level)
- Software Lifecycle Summary
- Software Hazard Analysis
- Software Requirements Summary
- Software Architecture Summary
- Traceability Matrix (high-level, dossier-focused)
(Supports MDR expectations for software-based medical devices)
Usability & Human Factors
- Intended User Profile
- Use-Related Risk Analysis (URRA)
- Usability Engineering Summary
(Aligned with IEC 62366 where applicable)
Clinical Evaluation & Performance
- Clinical Evaluation Plan (CEP) template
- Clinical Evaluation Report (CER) structure
- Clinical Evidence and Data Summary
- Literature Review template
- Performance Evaluation Summary
Post-Market Surveillance & Vigilance
- Post-Market Surveillance (PMS) Plan
- PMS Report template
- Vigilance and Incident Reporting procedure
- Periodic Safety Update Report (PSUR) structure
EU MDR Supporting Documentation
- Labeling and Instructions for Use (IFU) templates
- Symbols and labeling requirements overview
- Declaration and compliance statements (as applicable)
Format & Guidance
- Editable Word and PDF documents
- Fill-in-the-blank structure for all templates
- Embedded guidance explaining:
- MDR expectations for each section
- How documents map to Annex II & III
- How to tailor content to your device
Standards & Frameworks
Medical Device Regulation (EU) (2017/745), ISO 14971, IEC 62366
Who This Is For
- Digital health and SaMD teams preparing for EU MDR compliance
- Companies building MDR Technical Documentation
- Teams seeking structured templates rather than starting from scratch
Ready to prepare your EU MDR Technical Documentation?
Request access to receive structured, guided templates aligned with MDR requirements.