MDR-compliant technical file

For manufacturers seeking MDR compliance, a fundamental requirement is the technical documentation, often informally known as the technical file. The term "technical file" is widely used in the industry as professional lingo, but the MDR does not officially use this term. Instead, MDR (EU 2017/745) consistently refers to it as technical documentation.

This documentation serves as the backbone of regulatory compliance, containing all necessary evidence to prove that a medical device meets the requirements for safety, performance, and risk management. It must be prepared before a device is placed on the market and kept up to date throughout the device's lifecycle. MDR sets clear expectations regarding its structure and content, ensuring that every aspect of the device’s design, intended use, and manufacturing process is documented.

The documentation must be comprehensive yet well-organized, allowing Notified Bodies and regulatory authorities to assess compliance efficiently. Every manufacturer, regardless of their device classification, must maintain a technical file that aligns with the structure outlined in Annexes II and III of MDR.

The technical file must be clear, well-structured, and free of inconsistencies to avoid delays or rejection during the certification process. A properly maintained technical file ensures smoother audits, surveillance, and market surveillance inspections, eventually helping in obtaining CE marking.

One of the major challenges manufacturers face is keeping their technical documentation up to date. Since MDR emphasizes continuous compliance, the technical file is a living document (or rather set of documents) that must be updated whenever there are design changes, new clinical data, or emerging safety concerns. Post-market surveillance findings, risk assessments, and periodic safety updates must be reflected in the documentation.

The data contained within the file must be well-referenced, logically structured, and linked to the risk management and clinical evaluation processes. Poorly organized or incomplete documentation can lead to delays in approvals, costly re-submissions, or even rejection of CE certification applications.

While MDR sets out clear guidelines for technical documentation, it does not impose a fixed format. However, following the structure in Annex II (Technical Documentation) and Annex III (Post-Market Surveillance Documentation) ensures that all required elements are covered. Most manufacturers organize their documentation into sections covering device description, design and manufacturing details, risk management, clinical evaluation, labeling, and PMS activities.

Below, you will find information and templates for the key technical documents required for MDR compliance. They are structured in accordance with the technical documentation requirements outlined in Annexes II and III, ensuring a clear and organized approach to meeting regulatory expectations. These resources will help ensure that your technical documentation meets regulatory expectations, facilitating a smooth certification process.

1. Device description and specifications ▼

2. Information supplied ▼

3. Design and manufacturing ▼

• Description of design process including R&D site(s) identification
• Description of manufacturing
• Description of quality control
• Manufacturing site(s) identification
• Outsourced processes

4. GSPR and applied standards ▼

• List of applied standards
• GSPR Matrix

5. Risk management ▼

• Risk management plan
• Risk analysis and control
• Risk management report

6. Product verification and validation ▼

• Biological evaluation plan
• Biological compatibility tests
• Biological evaluation summary
• Verification plan
• Verification testing
• Verification summary
• Stability and shelf life
• Clinical evaluation plan
• Clinical evaluation report

7. Post market surveillance ▼

• Post-market surveillance plan
• PSUR
• PMCF Plan