Medical Device Technical File for EU MDR CE Marking
A medical device technical file, called technical documentation in the MDR, is the evidence that your device meets EU MDR 2017/745. It describes the device, proves it is safe and performs as intended, and must stay current for as long as the device is on the market. I3CGLOBAL prepares, reviews and maintains technical files for class I to class III devices worldwide.
At a glance
| Legal basis | Article 10(4), Annex II and Annex III of Regulation (EU) 2017/745 |
| Who prepares it | The legal manufacturer, for every device or device group |
| Who reviews it | A notified body for class Is, Im, Ir, IIa, IIb and III devices |
| Retention | At least 10 years after the last device is placed on the market, 15 years for implantable devices |
| Main parts | Six Annex II sections plus the Annex III post-market surveillance documents |
The basics
What Is Medical Device Technical Documentation?
Medical device technical documentation is the set of controlled documents that shows a device conforms to the EU Medical Device Regulation. Article 10(4) of MDR 2017/745 requires every manufacturer to draw it up before placing a device on the EU market, and to keep it current afterwards.
The terms are often used interchangeably. Under the old Medical Device Directive (MDD), this evidence was called the technical file, and many teams still call it the CE technical file. The MDR uses the term technical documentation. In practice, the MDR technical file and EU MDR technical documentation mean the same thing: the content defined in Annexes II and III.
A medical device technical file is not a single report. It links the device description, labelling, design and manufacturing data, the general safety and performance requirements, risk management, verification and validation, clinical evaluation and post-market surveillance into one traceable body of evidence. It supports the EU declaration of conformity and the CE mark, and it is the main document set a notified body or competent authority examines during medical device CE marking.
Annex II and III
What Does a Medical Device Technical File Contain?
Annex II sets six sections of technical documentation, and Annex III adds the post-market surveillance documents. Every medical device technical file follows this structure, although the depth of evidence depends on the device.
- 1. Device description and specificationIntended purpose, users, patient population, Basic UDI-DI (UDI), classification rule, variants, accessories and previous generations.
- 2. Information supplied by the manufacturerLabels, packaging and instructions for use in the languages of the countries where the device is sold.
- 3. Design and manufacturing informationDesign stages, manufacturing processes and their validation, and the sites and critical suppliers involved.
- 4. General safety and performance requirementsA GSPR checklist showing how each Annex I requirement is met, with standards applied and evidence referenced.
- 5. Benefit-risk analysis and risk managementThe risk management file and benefit-risk conclusion, normally to EN ISO 14971.
- 6. Product verification and validationPre-clinical tests, biocompatibility, electrical safety, software, sterilisation validation, shelf life and the clinical evaluation report.
- + Annex III post-market surveillancePMS plan, PMCF plan and either a PMS report (class I) or a PSUR (class IIa, IIb and III).
For the clause-by-clause breakdown, see the MDR technical documentation table of contents.
Device class
Does Every Device Need the Same Technical File?
No. Every device needs an Annex II and III medical device technical file, but the depth of evidence and the conformity route change with the risk class.
- Class I: the manufacturer self-declares conformity. A notified body is involved only for sterile, measuring or reusable surgical instrument aspects.
- Class IIa: a notified body assesses the technical documentation of representative devices.
- Class IIb: a notified body assesses representative devices per generic device group, and most implants device by device.
- Class III: every device is assessed, with the most demanding clinical evidence and an SSCP for implantable and class III devices.
To match your device to its classification rule and conformity route, see the types of MDR technical files, which covers class I to III, special rule devices, procedure packs and custom-made devices.
Assessment
How Do Notified Bodies Review MDR Technical Documentation?
For devices above class I, a notified body assesses the technical documentation as part of the conformity assessment under Article 52. How much it samples depends on the class.
| Class | Technical documentation assessment |
|---|---|
| Class I | No notified body review, except the sterile, measuring or reusable surgical instrument aspects |
| Class IIa | At least one representative device for each category of devices |
| Class IIb | At least one representative device per generic device group; every device for most class IIb implants |
| Class III | Every device, with clinical evaluation consultation for class III implantable devices under Article 54 |
The notified body checks that the file is complete, traceable and consistent: that the GSPR checklist points to real evidence, that the risk file matches the labelling and the clinical evaluation, and that the post-market plans fit the device. Gaps in a medical device technical file lead to non-conformities and delays, so a structured internal review before submission saves time.
Control
Who Keeps the Technical File, and for How Long?
The manufacturer owns the medical device technical documentation and must keep it available to competent authorities. The person responsible for regulatory compliance makes sure it is drawn up and kept current. Manufacturers outside the EU must also give their EU authorised representative access to a copy.
- Retention: at least 10 years after the last device covered by the EU declaration of conformity is placed on the market, and at least 15 years for implantable devices (Article 10(8)).
- Language: an official EU language accepted by the notified body, or by the competent authority for class I devices.
- Format: electronic files are accepted, provided they are controlled, searchable and can be supplied on request.
- Updates: the file is a living document. Update it after design or labelling changes, new standards, new risk or clinical findings and each PMS report or PSUR cycle.
After certification
How Is a Medical Device Technical File Kept Up to Date?
A medical device technical file does not end with the CE certificate. Under the MDR, post-market data must flow back into the file throughout the life of the device, and the notified body checks this at every surveillance audit.
- Post-market data: complaints, vigilance reports, PMCF results and literature feed the PMS report or PSUR, then the clinical evaluation report and the risk file.
- Change control: every design, supplier, labelling or software change needs an impact assessment, and significant changes must be notified to the notified body before they are implemented.
- Standards updates: new versions of harmonised standards require a gap assessment and, where needed, new testing or justification in the GSPR checklist.
- Surveillance audits: the notified body samples the medical device technical file during annual audits and at recertification.
Many manufacturers outsource this maintenance so the file stays audit-ready without tying up their own regulatory team.
Special cases
What Extra MDR Technical Documentation Do Special Devices Need?
The Annex II structure of a medical device technical file is the same for every device, but some device types need additional evidence inside sections 3 to 6. Planning these early is one of the biggest time savers in a technical documentation project.
Software and apps
Standalone software follows Rule 11 and needs software life-cycle evidence, usually to IEC 62304, plus cybersecurity and usability data. See software CE marking.
Sterile devices
Validated sterilisation and packaging, sterility assurance and shelf-life data. See sterilisation validation.
Implantable devices
Device-by-device review for most class IIb implants and all class III devices, an SSCP and an implant card under Article 18.
Active and electrical devices
Electrical safety and EMC testing, usually to the IEC 60601 series. See electrical safety testing.
Systems and procedure packs
Article 22 statements rather than a full technical file for each pack. See systems and procedure packs.
Usability-critical devices
A usability engineering file, usually to IEC 62366-1. See medical device usability.
Common gaps
What Are the Most Common MDR Technical File Deficiencies?
Most notified body questions on a medical device technical file come from a small set of recurring gaps. Closing them before submission is faster than answering non-conformities afterwards.
- Unclear intended purpose: different wording in the description, labelling, risk file and clinical evaluation.
- GSPR checklist without evidence: requirements marked “applicable” with no document reference or standard version.
- Weak clinical evidence: equivalence claims that do not meet MDR rules, or outdated literature searches.
- Disconnected risk management: hazards that never reach the IFU warnings or the PMS plan.
- Old MDD structure: files simply renamed rather than rebuilt to Annex II and III.
- Thin post-market plans: PMS and PMCF plans without data sources, indicators or timelines.
Check your own file against our MDR technical documentation checklist.
Process
How Do You Prepare MDR Technical Documentation?
Preparing a medical device technical file works best as a planned project that runs alongside design control and the quality management system.
- 1. Define and classify the deviceFix the intended purpose, then apply the Annex VIII rules to confirm the class and conformity route.
- 2. Plan the evidenceList the applicable GSPRs, standards, tests and clinical data, and identify what already exists.
- 3. Run a gap analysisCompare existing documents against the MDR and prioritise what is missing.
- 4. Generate missing evidenceComplete testing, risk management, usability and the clinical evaluation report.
- 5. Compile the technical fileAssemble the Annex II and III sections, starting from our MDR technical file templates if helpful.
- 6. Review and submitCheck traceability and consistency, then submit to the notified body or sign the declaration of conformity.
Related QMS documents are covered by our MDR procedures and templates.
Cost and timeline
How Much Does a Medical Device Technical File Cost?
The cost of a medical device technical file depends on the device class, how much evidence already exists and how much of the file you want us to prepare. Notified body fees are charged separately by the notified body.
Class I
From USD 5,000Consulting for MDR technical documentation and CE marking support, depending on the service package.
Class III
Up to USD 23,000Consulting for the most demanding files, including notified body coordination.
Timeline
Weeks to monthsA few weeks for class I with existing evidence; several months for class IIb or III needing new testing or clinical data.
See the full MDR CE marking cost breakdown, estimate your project with the MDR CE marking cost calculator, or compare notified body fees.
How we help
Medical Device Technical Documentation Services
I3CGLOBAL’s medical device technical documentation consultants prepare MDR technical files for class I to class III devices, from single products to large portfolios. You can hand over the full file or use us for specific sections. For full project support, see our EU MDR consultants.
Technical file preparation
Full MDR technical file preparation and compilation to Annex II and III, ready for notified body submission.
Gap analysis and remediation
Review of existing MDD or MDR files, a prioritised gap list and closure of the missing evidence.
Clinical and post-market documents
Clinical evaluation reports, PMCF, PMS plans, PMS reports and PSURs.
Notified body support
Responses to technical documentation non-conformities and questions until certification.
Technical documentation outsourcing
Ongoing maintenance of your files after certification, including change assessments and periodic updates.
EU representative and EUDAMED
EU authorised representative, UDI assignment and EUDAMED registration for non-EU manufacturers.
Work with I3CGLOBAL
Need an MDR Technical Documentation Consultant?
Tell us about your device, its class and the documents you already have, and we will send a fixed-price proposal for your technical file.
- Annex II and III technical file
- Gap analysis of MDD or MDR files
- Clinical evaluation and PMS documents
- Notified body support
Request your proposal
Share your device details and we will prepare a medical device technical file proposal.
FAQs
Medical Device Technical File: Common Questions
Is a technical file the same as MDR technical documentation?
Yes, in practice. “Technical file” is the MDD term, and “technical documentation” is the MDR term. Both refer to the evidence that a device conforms to the regulation.
Does a class I device need a technical file?
Yes. Class I manufacturers must draw up technical documentation under Annexes II and III before signing the EU declaration of conformity, even when no notified body is involved.
How long must MDR technical documentation be kept?
At least 10 years after the last device is placed on the market, and at least 15 years for implantable devices, under Article 10(8) of the MDR.
Can the technical file be kept in electronic format?
Yes. Electronic files are accepted when they are under document control and can be provided to a notified body or competent authority on request.
How often should a medical device technical file be updated?
Whenever the device, its labelling, its risks or the applicable standards change, and at each PMS report or PSUR update. A PSUR is updated at least annually for class IIb and III devices and at least every two years for class IIa devices.
How long does MDR technical file preparation take?
A few weeks for a class I device with existing evidence, and several months for class IIb or III devices that need new testing or clinical data.
How much does medical device technical documentation cost?
At I3CGLOBAL, consulting for MDR technical documentation and CE marking support ranges from USD 5,000 for class I devices to USD 23,000 for class III devices, depending on the class and service package. Notified body fees are separate.
What is the difference between MDD and MDR technical files?
The MDR defines the content in more detail, requires stronger clinical evidence, adds UDI, the SSCP and PSUR, and expects continuous updating through post-market surveillance.
Who is responsible for the technical documentation?
The legal manufacturer. Its person responsible for regulatory compliance (PRRC) must make sure the technical documentation is drawn up and kept up to date.
Can you prepare the clinical evaluation report as part of the technical file?
Yes. I3CGLOBAL prepares the clinical evaluation report, PMCF plan and post-market documents as part of the same technical documentation project.