Technical File
Technical File
Compile comprehensive documentation package demonstrating device compliance with requirements for CE marking.
Summary
The Technical File is the comprehensive documentation package that demonstrates your medical device’s compliance with EU MDR requirements. It contains all essential information about your device’s design, manufacturing, safety, performance, and clinical evidence, serving as the foundation for your Declaration of Conformity and regulatory submissions.Why is Technical File important?
The Technical File serves as the regulatory backbone of your medical device certification in the EU. It provides regulatory authorities and notified bodies with complete evidence that your device meets all General Safety and Performance Requirements (GSPR) under MDR 2017/745. Without a properly structured Technical File, you cannot obtain CE marking or legally market your device in Europe. The document also serves as your defense mechanism during regulatory inspections and provides the foundation for post-market surveillance activities and clinical evaluations.Regulatory Context
Under EU MDR 2017/745:- Annex II defines Technical File requirements for all device classes
- Annex III specifies additional requirements for higher-risk devices
- Must be available before placing device on market
- Required for notified body assessment for Class Is, Im, Ir, IIa, IIb, and III devices
Special attention required for:
- Software lifecycle documentation according to IEC 62304
- Clinical evaluation and post-market clinical follow-up (PMCF) documentation
- Risk management documentation according to ISO 14971
- Unique Device Identification (UDI) and EUDAMED registration requirements
Guide
Your Technical File must follow the structured format defined in Annex II of MDR 2017/745. The document serves as a comprehensive repository that links together all your regulatory documentation and demonstrates systematic compliance with EU requirements.Section 1: Device Description and Specifications
Device Identification: Document your device’s trade name, software version, and Basic UDI-DI. Include a detailed description of your device’s principles of operation and how it achieves its intended purpose. For software devices, describe the clinical algorithms, data processing methods, and user interface functionality. Intended Purpose and Users: Reference your Intended Use document and provide specific details about indications for use, patient population, contraindications, and intended users. Include any clinical claims that are substantiated through your clinical evaluation process. Classification and Codes: State your device’s MDR classification with detailed justification according to Annex VIII classification rules. Include your EMDN code selection and rationale for choosing the most appropriate nomenclature category.Section 2: Information Supplied by the Manufacturer
Labeling Documentation: Reference your Device Label and Instructions for Use documents. For software devices, specify how electronic IFU (e-IFU) is provided according to EU 207/2012 requirements. Include the URL location where users can access electronic instructions. Marketing Materials: Include copies of all promotional materials and marketing content that will be used to promote your device. Ensure all claims made in marketing materials are substantiated by your clinical evidence.Section 3: Design and Manufacturing Information
Design Stages: Document your software development lifecycle according to your SOP for Integrated Software Development. Include evidence of design reviews, verification and validation activities, and design transfer processes. Software Architecture: Reference your Software Architecture document and provide details about software items, SOUP (Software of Unknown Provenance) components, and cybersecurity measures. Include your software bill of materials and version control information. Risk Management: Reference your Risk Management Plan, Risk Assessment, and Risk Management Report. Demonstrate how you’ve systematically identified, analyzed, and controlled risks throughout your device lifecycle.Section 4: General Safety and Performance Requirements
GSPR Compliance: Reference your GSPR Checklist that demonstrates compliance with all applicable requirements in Annex I of MDR 2017/745. Address each requirement systematically and provide evidence of compliance through design features, testing, or clinical data. Standards Compliance: List all harmonized standards you’ve applied, such as EN ISO 13485 for quality management, ISO 14971 for risk management, and IEC 62304 for medical device software. Demonstrate how compliance with these standards supports GSPR compliance.Section 5: Benefit-Risk Analysis and Risk Management
Clinical Evidence: Reference your Clinical Evaluation Plan and Clinical Evaluation Report that demonstrate your device’s clinical safety and performance. Include your benefit-risk analysis that shows clinical benefits outweigh residual risks. Post-Market Surveillance: Reference your Post-Market Surveillance Plan and describe how you’ll monitor device performance and safety after market placement. Include your PMCF activities and how clinical evidence will be updated.Section 6: Product Verification and Validation
Testing Documentation: Reference all verification and validation reports including software testing, usability evaluation, and any applicable bench testing. Demonstrate that your device meets all specified requirements under normal and fault conditions. Traceability: Include your Traceability Matrix that links user needs through system requirements to verification and validation activities. This demonstrates systematic coverage of all requirements.Example
Scenario
You’ve developed a Class IIa software application for remote cardiac monitoring that analyzes ECG data and alerts healthcare providers to arrhythmias. You need to compile your Technical File for notified body submission and CE marking.Technical File Structure Example
1. Device Description and Specifications Device Trade Name: CardioWatch ProSoftware Version: v2.1.0
Basic UDI-DI: 4012345678901 Device Description: CardioWatch Pro is a software medical device that continuously analyzes ECG data from compatible monitoring devices. The software uses proprietary algorithms to detect cardiac arrhythmias and provides real-time alerts to healthcare professionals through a secure web interface. Intended Purpose: Software for continuous monitoring and analysis of cardiac rhythm patterns in hospital settings for healthcare professionals to aid in the detection of cardiac arrhythmias. Classification: Class IIa according to Rule 11 of Annex VIII - software intended to provide information for decisions with diagnosis or therapeutic purposes. 2. Information Supplied by the Manufacturer Device Label: Reference document DL-001-2024
Instructions for Use: Reference document IFU-001-2024
Electronic IFU Location: https://www.cardiowatch.com/ifu
Marketing Content: Reference document MC-001-2024 3. Design and Manufacturing Information Software Development Plan: Reference document SDP-001-2024
Software Architecture: Reference document SA-001-2024
Risk Management Plan: Reference document RMP-001-2024
Design Review Records: Five design reviews completed per SOP-ISD-001 4. General Safety and Performance Requirements GSPR Checklist: Reference document GSPR-001-2024 demonstrating compliance with all applicable requirements in Annex I
Standards Applied:
- EN ISO 13485:2016 - Quality management systems
- ISO 14971:2019 - Risk management
- IEC 62304:2006 - Medical device software
- IEC 62366-1:2015 - Usability engineering
Benefit-Risk Analysis: Clinical benefits of early arrhythmia detection outweigh software-related risks
Post-Market Surveillance Plan: Reference document PMSP-001-2024 6. Verification and Validation Software System Test Report: Reference document SSTR-001-2024
Usability Evaluation Report: Reference document UER-001-2024
Traceability Matrix: Reference document TM-001-2024
Q&A
What documents must be included in my Technical File?
What documents must be included in my Technical File?
Your Technical File must include all documents referenced in Annex II of MDR 2017/745. Key documents include: Intended Use, Device Classification, Risk Management documentation, Clinical Evaluation Report, GSPR Checklist, Instructions for Use, Device Label, Software Architecture (for software devices), and all verification and validation reports. The exact list depends on your device type and classification.
How detailed should my Technical File be for software medical devices?
How detailed should my Technical File be for software medical devices?
For software devices, your Technical File must include comprehensive software lifecycle documentation according to IEC 62304. This includes software development plan, software architecture, software requirements, verification and validation records, software bill of materials including SOUP components, and cybersecurity documentation. The level of detail should be proportional to your software safety classification.
When do I need to update my Technical File?
When do I need to update my Technical File?
You must update your Technical File whenever there are significant changes to your device that affect safety, performance, or intended use. This includes major software updates, changes in clinical evidence, new risk assessments, or modifications to manufacturing processes. Minor bug fixes typically don’t require Technical File updates, but document the rationale in your change control records.
How long must I maintain my Technical File?
How long must I maintain my Technical File?
You must maintain your Technical File for at least 10 years after the last device covered by it has been placed on the market, or 15 years for implantable devices. The file must be readily available for regulatory authorities and notified bodies upon request, and you must keep it updated with post-market surveillance data and clinical evidence.
Can I use the same Technical File for multiple software versions?
Can I use the same Technical File for multiple software versions?
You can use the same Technical File for multiple software versions if the changes don’t affect the device’s safety, performance, or intended use. However, you must update relevant sections (like software version, UDI-PI, verification records) and maintain traceability of changes. Significant software updates that affect clinical functionality typically require a new or substantially updated Technical File.