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.