A technical file is the structured collection of documents used to demonstrate that a medical device complies with applicable regulatory requirements. Under the EU Medical Device Regulation (MDR 2017/745), it contains evidence covering the device’s design, manufacture, safety, performance, clinical evaluation and post-market activities.
The technical file supports conformity assessment and CE marking while providing regulators and notified bodies with a clear, traceable record of how compliance was established.
What Is Included in a Medical Device Technical File?
Technical documentation is primarily structured according to Annex II and Annex III of the EU MDR. The level of detail depends on the device’s classification, complexity, technology and associated risks.
A complete technical file typically includes the following sections:
Device Description and Specification
This section identifies the device, its variants, accessories, operating principles and Basic UDI-DI. It also defines the device’s intended use, target patient population, intended users, indications, contraindications and use environment.
The description should be consistent throughout the technical documentation, clinical evidence, risk-management records and product labelling.
Labelling and Instructions for Use
The technical file contains all labels, symbols, packaging information and the current Instructions for Use (IFU). These materials must accurately communicate the device’s intended purpose, operating instructions, warnings, precautions, contraindications and residual risks.
Design and Manufacturing Information
This section explains the device architecture, key components, materials, manufacturing processes, suppliers, manufacturing sites and quality controls. It should provide enough information for an assessor to understand how the device is designed and consistently produced.
General Safety and Performance Requirements
Manufacturers must demonstrate compliance with the General Safety and Performance Requirements in Annex I of the EU MDR. A GSPR checklist normally identifies each applicable requirement, the method used to demonstrate conformity and the supporting evidence.
Risk Management and Benefit-Risk Evaluation
The technical file must contain a risk-management plan, hazard analysis, risk-control measures, residual-risk evaluation and a risk-management report. These records should align with ISO 14971 and support the device’s overall benefit-risk determination.
Risk controls must also remain consistent with design outputs, verification results, labelling and post-market information.
Product Verification and Validation
Objective evidence is required to demonstrate that the device meets its specifications and performs as intended. The verification and validation process may include:
- Electrical safety and electromagnetic compatibility testing, where applicable, against standards such as IEC 60601
- Biocompatibility evaluation in accordance with ISO 10993
- Mechanical, environmental, packaging and transportation testing
- Sterilization and shelf-life validation
- Usability engineering and use-related risk evaluation
- Software lifecycle documentation aligned with IEC 62304
- Performance, bench and clinical testing
Each requirement should be traceable to the corresponding design output, verification method and test result.
Clinical Evaluation
The clinical evaluation demonstrates that the device achieves its intended clinical benefits and maintains an acceptable safety profile. It normally includes a clinical evaluation plan, literature review, appraisal of clinical data, equivalence justification where applicable and a Clinical Evaluation Report.
Post-Market Surveillance Documentation
Annex III requires manufacturers to document how device performance and safety will be monitored after market introduction. Depending on device classification, the technical file may contain a post-market surveillance plan, Periodic Safety Update Report and a Post-Market Clinical Follow-up plan and report.
Why Is the Technical File Important?
An incomplete or inconsistent technical file can delay conformity assessment, create notified-body findings and prevent timely CE marking. It can also make regulatory inspections, device changes and post-market investigations more difficult.
Well-organized technical documentation provides traceability from user needs and regulatory requirements through risk controls, design outputs, testing, clinical evidence and post-market monitoring. This enables reviewers to evaluate the device without relying on undocumented assumptions.
Maintaining the Technical File
A technical file is a controlled, living set of documents rather than a one-time submission. It should be reviewed and updated when there are changes to the device, manufacturing process, supplier, software, intended purpose, applicable standards or risk profile.
Post-market information—including complaints, vigilance reports, trend data and PMCF findings—should also feed back into the risk-management and clinical-evaluation records. A structured product lifecycle management process helps ensure that changes are assessed, approved and reflected consistently across the documentation.
Under the EU MDR, technical documentation is generally retained for at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market. For implantable devices, the minimum period is generally 15 years.
Common Technical File Challenges
Common problems include inconsistent device descriptions, missing evidence, outdated standards, weak GSPR mapping and poor traceability between requirements, risks and verification results.
Another frequent issue is updating one document without assessing its impact on connected records. For example, a design change may also require updates to the risk analysis, test reports, clinical evaluation, labelling and post-market plans.
Clear document ownership, version control and formal change assessment help maintain a coherent and audit-ready technical file.
How SJML Supports Technical Documentation
SJML provides medical device compliance services to help manufacturers create, review and remediate technical documentation for regulatory submissions and audits.
Support may include technical-file gap assessments, GSPR mapping, risk-management documentation, clinical and post-market documentation, design-history review and evidence traceability. SJML’s engineering and regulatory teams can also help align design, testing and manufacturing records with the applicable regulatory requirements.
Contact SJML to discuss technical-file preparation, remediation or lifecycle maintenance for your medical device.
Frequently asked questions
No. A Technical File is the EU MDR documentation that demonstrates conformity for the whole device, while a Design History File (DHF) is the US design-controls record. They overlap heavily and draw on the same evidence, but the Technical File is broader and includes clinical evaluation and post-market surveillance content that the DHF does not.
Yes. Every medical device placed on the EU market needs technical documentation under EU MDR 2017/745, including Class I devices. The required content is the same in scope, but the depth and the level of external review differ. Most Class I manufacturers self-certify, while higher-risk classes undergo notified body assessment of the file.
Under EU MDR, the manufacturer must keep the Technical File available to authorities for at least 10 years after the last device covered by it is placed on the market. For implantable devices, the period is at least 15 years. The file must stay current throughout, reflecting design changes, complaints, and post-market data.
For most devices above Class I, a notified body reviews the Technical File during conformity assessment before CE marking. Competent authorities can also request it at any time, including during market surveillance or after an incident. Internally, QA and regulatory teams review it before submission and at each significant design or process change.