Technical File is a comprehensive set of documentation required by EU MDR that demonstrates a medical device meets safety and performance requirements, including design, manufacturing, and clinical evidence.
Complete Guide to Technical File
The Technical File (also called Technical Documentation) is a mandatory requirement under the European Union Medical Device Regulation (EU MDR 2017/745). It provides comprehensive evidence that a medical device meets applicable safety and performance requirements.
What a Technical File contains:
Device Description and Specifications (Annex II):
- Device identification and intended purpose
- Design and manufacturing information
- Product specifications and variants
- Materials used and biological safety assessment
- Complete labeling and instructions for use
Quality Management and Manufacturing:
- ISO 13485 certification and quality procedures
- Manufacturing process description
- Supplier and subcontractor information
- Sterilization validation (if applicable)
- Software validation documentation (if applicable)
Risk Management (ISO 14971):
- Hazard identification and risk analysis
- Risk evaluation and control measures
- Risk-benefit analysis
- Residual risk assessment
Clinical Evaluation (Annex XIV):
- Clinical evaluation plan and report
- Literature review and clinical data
- Post-Market Clinical Follow-up (PMCF) plan
- Clinical investigation data (if applicable)
Performance Evaluation:
- Verification and validation testing results
- Bench testing and biocompatibility data
- Usability and human factors engineering
- Electromagnetic compatibility (EMC) testing
Regulatory and Standards Compliance:
- EU Declaration of Conformity
- Applicable harmonized standards (e.g., ISO 13485, ISO 14971, IEC 60601)
- Certificate of Free Sale
- Previous regulatory approvals in other jurisdictions
Post-Market Surveillance (Annex III):
- PMS plan and periodic safety update reports (PSURs)
- Complaint handling procedures
- Field safety corrective actions (FSCAs)
Technical File vs Design Dossier: For Class III and implantable Class IIb devices, a Design Dossier (subset of Technical File) must be submitted to the Notified Body for design examination.
Maintenance Requirements: The Technical File must be kept up-to-date throughout the device lifecycle and retained for at least 10 years after the last device is placed on the market.
Related Terms
More Documentation
View allA compilation of records describing the design history of a finished medical device, required by FDA 21 CFR Part 820.
All written, printed, or graphic information appearing on the medical device, its packaging, or accompanying the device, including instructions for use and safety information.
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