How to Prepare MDR Technical Documentation for Rollators – A Step-by-Step Guide

Under MDR (EU) 2017/745, all medical devices—including Class I mobility aids like rollator walkers—must have a complete, structured technical documentation file. This article outlines what’s required, how to organize it, and how RELAXSMITH ROLLATOR builds exemplary compliance-ready files for EU review.

1. Why Technical Documentation Matters

• Legal Requirement: Required under Annex II and Annex III of MDR 2017/745.
• Inspection Target: EU authorities or distributors may request immediate access during audits or registration.
• Brand Trust: Professional documentation positions your company as reliable and competent.

2. Core Components of the Technical File

1. Device Description: Photos, exploded diagrams, bill of materials (BOM), and intended purpose in EU languages.
2. Design & Manufacturing Info: Production drawings, design changes, production flowcharts, supplier qualifications.
3. GSPR Checklist: A complete checklist of the General Safety and Performance Requirements with reference to standards (e.g., EN 12182, EN ISO 14971).
4. Risk Management File: Includes ISO 14971-compliant hazard analysis and risk control documentation.
5. Clinical Evaluation Report (CER): Summary of clinical data and device equivalence justification.
6. Labeling & IFU: Sample labels with CE mark and UDI, user manual (Instructions for Use) in multiple EU languages.
7. Post-Market Surveillance (PMS) Plan: Including vigilance system and complaint handling flow.

3. Best Practices from RELAXSMITH ROLLATOR

• Structure: RELAXSMITH ROLLATOR uses color-coded tabs for quick navigation—ideal for notified bodies and distributors.
• Translation: All core documents are professionally translated into DE, FR, IT, ES, and NL.
• Cross-Referencing: The GSPR checklist links directly to page numbers in the CER, BOM, and user manual.

4. Common Mistakes to Avoid

• Missing CER: Even Class I devices need documented clinical justification.
• Uncontrolled revisions: Files must track design changes and approval signatures.
• No PMS linkage: Surveillance strategy must be active and demonstrable, not just a formality.

5. Final Checks Before Audit or Submission

• Digital + Physical: Keep both USB and printed versions organized by annex and revision date.
• Third-Party Review: Ask a notified body or regulatory expert to conduct a dry-run audit.
• Train Your Team: Ensure sales, support, and QA staff understand how to explain documentation content.