Building an EU MDR Technical File That Holds Up to Notified Body Review
Build the Annex II file around the GSPR checklist, feed it with post-market data, and update it through change control.
In Short
- The GSPR checklist is the spine.
- PMS data keeps the file live.
- Keep it 10 years, 15 for implants.
The Medical Device Production Guide
Built to revision. Inspected. On record.
- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
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The Medical Device Production Guide
Built to revision. Inspected. On record.
Under Regulation (EU) 2017/745, every device placed on the EU market needs technical documentation showing how it meets the general safety and performance requirements. Annex II sets the content of the file and Annex III the post-market surveillance documentation. This guide covers the structure, how the file stays current and where manufacturers often fall short. It is orientation, not regulatory advice. Sources checked 4 Oct 2026.
What Annex II asks for
Annex II lists six blocks: device description and specification, including variants and accessories; information supplied by the manufacturer, meaning labels and instructions for use; design and manufacturing information, including the sites involved; the general safety and performance requirements with the method used to show conformity to each; the benefit-risk analysis and risk management; and product verification and validation, including pre-clinical and clinical evidence. Each block should point to controlled source documents rather than pasted copies that drift out of date.
Annex II at a Glance
| Block | Typical evidence |
|---|---|
| Device description | Specification, variants, accessories, UDI-DI |
| Manufacturer information | Labels and instructions for use |
| Design and manufacturing | Process descriptions, sites |
| GSPR | Checklist with standards and references |
| Benefit-risk and risk management | Risk file and conclusion |
| Verification and validation | Test reports, clinical evaluation |
- Device description
- Typical evidence
- Specification, variants, accessories, UDI-DI
- Manufacturer information
- Typical evidence
- Labels and instructions for use
- Design and manufacturing
- Typical evidence
- Process descriptions, sites
- GSPR
- Typical evidence
- Checklist with standards and references
- Benefit-risk and risk management
- Typical evidence
- Risk file and conclusion
- Verification and validation
- Typical evidence
- Test reports, clinical evaluation
The GSPR checklist is the spine
Annex I lists the general safety and performance requirements (GSPR). Notified bodies commonly expect a checklist that states, for each requirement, whether it applies, the harmonised standard or common specification used, and the document that proves it.
More on the GSPR checklist is the spine
A requirement marked not applicable needs a reason. When a standard is revised, the checklist shows exactly which entries need a fresh look.
Post-market surveillance belongs in the file
Annex III requires a post-market surveillance plan and, depending on class, a PMS report for class I devices (Article 85) or a periodic safety update report for class IIa, IIb and III (Article 86). Complaints, trends, field safety corrective actions and literature feed back into risk management and the clinical evaluation, so the technical documentation is a living record rather than a submission snapshot.
Keeping it current through change
A design, supplier, labelling or process change can affect GSPR entries, the risk file, the clinical evaluation and the declaration of conformity. Route each change through change control with an impact assessment that names the technical documentation sections to update, and tell your notified body about substantial changes as your agreement requires.
Worked Example: a Sterile Pouch Supplier Change
More on keeping it current through change
Article 10(8) requires the documentation to stay available for at least 10 years after the last device is placed on the market, or 15 years for implantable devices.
Transition dates and who decides
Regulation (EU) 2023/607 extended transition for legacy devices to 31 December 2027 for class III and most implantable class IIb devices, and 31 December 2028 for other class IIb, class IIa, and sterile or measuring class I devices (Article 120(3a), as amended). Conditions apply, including a quality management system in place and a notified body application by 26 May 2024 and a signed agreement by 26 September 2024 (Article 120(3c)).
More on transition dates and who decides
The person responsible for regulatory compliance (Article 15) and your notified body make the conformity decisions; software only keeps the evidence organised and traceable.
Questions
Is a technical file the same as a design history file?
No. A US design history file records design controls. MDR technical documentation is broader and also covers GSPR conformity, labelling, manufacturing and post-market data. Much evidence can be shared if it is controlled once.
How long must we keep the technical documentation?
At least 10 years after the last device covered by the EU declaration of conformity is placed on the market, or 15 years for implantable devices, under Article 10(8).
Do class I devices need a PSUR?
No. Class I manufacturers prepare a PMS report under Article 85. Periodic safety update reports under Article 86 apply to class IIa, IIb and III devices.
Where does V5 fit?
V5 keeps controlled documents with revision history, change control with impact assessment, complaints, CAPA and device production records linked. Your regulatory team writes the file and your notified body assesses it.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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