How to Prepare Your Technical Documentation for MDR Compliance

Introduction

Under the EU Medical Device Regulation (MDR), technical documentation plays a central role in proving product safety, performance, and regulatory compliance. Unlike the previous MDD, MDR requires more detailed, structured, and continuously updated documentation. Failing to meet these requirements can delay certification or even block market access.

1. Essential Components of Technical Documentation

To comply with MDR, your technical file should include:

• Device Description & Specifications: Clear details on intended purpose, design, and components.
• Risk Management File: Following ISO 14971, identifying hazards, mitigation measures, and residual risks.
• Clinical Evaluation Report (CER): Evidence of safety and performance based on clinical data.
• Biological Evaluation: As per ISO 10993, ensuring biocompatibility.
• Post-Market Surveillance (PMS) Plan: Strategy for monitoring safety and performance after market release.
• Labeling & Instructions for Use (IFU): Must meet MDR format and language requirements.
• UDI (Unique Device Identification): Proper coding and labeling for traceability.

2. Structure and Organization

Your documentation should follow a logical structure to make review easier for notified bodies:

• General information
• Design and manufacturing details
• Risk analysis and mitigation
• Clinical data
• Post-market plans

Using templates or modular documentation systems can speed up preparation and updates.

3. Best Practices for Compliance

• Keep records up to date—MDR requires a "living document" approach.
• Use cross-references to link related sections (e.g., risk management ↔ clinical evaluation).
• Involve multidisciplinary teams (regulatory, engineering, clinical, quality) in preparation.
• Regularly review notified body feedback and align with MDCG guidance documents.

4. Common Mistakes to Avoid

• Copy-pasting outdated MDD files without proper updates.
• Missing or insufficient clinical data.
• Poorly defined intended use or risk-benefit analysis.
• Lack of alignment with harmonized standards.