Master Technical Documentation under MDR 2017/745

Mastering Technical Documentation under MDR 2017/745

In the world of medical device registration, your technical documentation (TD) isn't just surface work. It is the hidden foundation that Notified Bodies examine first. Under MDR 2017/745, your TD serves as your device’s identity card, proving it meets rigorous safety and performance standards.

The 7 Essential Pillars of Technical Documentation

Your TD should not be a collection of loose files but a structured, coherent, and evolving system guided by Annex II and III of the MDR. It rests on seven critical pillars:

1. Device Description & Specification: Defining what the device is and its variants.
2. Information Supplied by Manufacturer: Labels, packaging, and Instructions for Use (IFU).
3. Design & Manufacturing Information: Blueprints and the processes used to build the device.
4. GSPR (General Safety & Performance Requirements): The checklist proving compliance with Annex I.
5. Benefit-Risk Analysis & Risk Management: Systematic management throughout the product lifecycle.
6. Product Verification & Validation (V&V): Including bench testing and clinical evaluation.
7. Post-Market Surveillance (PMS): Plans for monitoring the device once it is in use.

Mastering the 3Cs: Clarity, Consistency, and Connectivity

To avoid infinite feedback loops with reviewers, your documentation must adhere to the 3C principle:

• Clarity: Write for the reviewer. Use simple, precise summaries and one-sheet conclusions for complex risk or clinical data.
• Consistency: Use a single intended purpose across every document. Use the same terminology and logic throughout.
• Connectivity: Cross-reference documents clearly. A change in design impacts risk, which impacts clinical data—trace these connections.

Best Practices for Compilation

• Create a V&V Matrix: Maintain clear traceability from User Requirements (URS) to Functional Requirements (FRS).
• Use Searchable Formats: Ensure digital files are indexed and hyperlinked for easy navigation.
• Summary Documents: Provide reviewers with a high-level roadmap of your TD structure.
• Regular Updates: Treat your TD as a living ecosystem, not a one-time project.

Get Started with Templates

You don't have to start from scratch. Use these specialized templates to build a compliant structure:

• GSPR Template: A predefined list of standards, documents, and methods (https://lnkd.in/eE2i43v7).
• Technical Documentation Template: A solid structure with concrete writing examples (https://lnkd.in/eNcS4aMG).

Clear documentation equals faster reviews and a faster path to helping patients.