What is a Technical File? Guide to MDR Technical Documentation & SaMD

What is a Technical File – and Why Is It the Key to CE Marking?

A Technical File—formally referred to as Technical Documentation under the EU Medical Device Regulation (MDR 2017/745) and IVDR (2017/746)—is the comprehensive, legally mandated evidence package demonstrating that a medical device meets all applicable safety, quality, and clinical performance requirements.

Without complete and up-to-date Technical Documentation, a manufacturer cannot sign an EU Declaration of Conformity or obtain CE marking—whether the product is a physical medical device, embedded firmware, or standalone Software as a Medical Device (SaMD).

What Must an MDR Technical File Contain? (Annex II & Annex III)

EU MDR structures Technical Documentation across two primary annexes: Annex II (pre-market conformity evidence) and Annex III (Post-Market Surveillance).

MDR Annex II: The 6 Core Sections

1. Device Description and Specification: Product name, Basic UDI-DI, Intended Purpose, indications, contraindications, target users/patients, risk classification (Annex VIII), principles of operation, and overview of previous generations or similar devices.
2. Information Supplied by the Manufacturer: Packaging labels, symbols, and Instructions for Use (IFU) in applicable EU Member State languages, aligned with marketing claims.
3. Design and Manufacturing Information: System architecture, design stages, manufacturing workflows, and critical supplier controls governed by your QMS.
4. General Safety and Performance Requirements (GSPR – Annex I): The central GSPR checklist mapping every Annex I requirement to harmonized standards, common specifications, and exact document/section evidence references.
5. Benefit-Risk Analysis and Risk Management: Complete ISO 14971 Risk Management documentation demonstrating that clinical benefits outweigh residual risks.
6. Product Verification and Validation: Objective test reports covering preclinical/bench testing, electrical safety/EMC, biocompatibility, usability engineering (IEC 62366-1), software V&V, and the Clinical Evaluation Report (CER).

MDR Annex III: Post-Market Surveillance (PMS) Documentation

• PMS Plan & PMCF Plan: Systematic procedures for collecting real-world clinical feedback, complaints, vigilance data, and literature updates.
• PMS Report (Class I) or PSUR – Periodic Safety Update Report (Class IIa, IIb & III).

Special Considerations for SaMD and AI-Enabled Devices

• Rule 11 Classification (MDCG 2019-11): Most medical software falls into Class IIa or higher, requiring Notified Body review of the Technical File.
• Software Lifecycle (IEC 62304 & IEC 82304-1): Full traceability from user needs and software requirements to architecture, SOUP inventory, and verification tests.
• Cybersecurity & AI Governance: Threat modeling, SBOM, vulnerability management (IEC 81001-5-1), and—for AI/ML devices—dataset representativeness, bias controls, and clinical/technical performance per MDCG 2020-1.

Technical File vs. Medical Device File vs. DHF

• Technical File / Technical Documentation (EU MDR/IVDR): Regulatory submission dossier structured around Annex II & III.
• Medical Device File – MDF (ISO 13485 Clause 4.2.3): Product specification and procedure dossier within your QMS.
• Design History File – DHF (FDA 21 CFR Part 820 / QMSR): US compilation proving development under approved Design Controls.

Glaze Medical's senior consultants (20–30+ years of experience) structure unified Design Control architectures that satisfy EU MDR, ISO 13485, and US FDA simultaneously—including gap analyses, traceability matrices, and pre-submission Notified Body reviews. Explore our consulting services or contact us for an informal conversation.

Frequently Asked Questions About Technical Files (FAQ)

Do Class I medical devices also require a Technical File under EU MDR?

Yes. Every risk class under EU MDR—including self-certified Class I devices—must have complete Technical Documentation per Annex II and III before signing the EU Declaration of Conformity and affixing the CE mark.

What language should an EU MDR Technical File be written in?

Technical Documentation is written in English by industry convention for Notified Body review, whereas labels and Instructions for Use (IFU) must be provided in the official national languages of the EU countries where the device is marketed.

How long must a Technical File be retained?

At least 10 years after the last device has been placed on the market (and at least 15 years for implantable devices) per MDR Article 10(8).