MDR Technical Documentation Requirements: Annex II and III Table of Contents
EU MDR 2017/745 sets out exactly what technical documentation must contain. Annex II covers the device, its design, safety and performance evidence, and Annex III covers post-market surveillance. This page sets out the full table of contents, clause by clause, so you can structure your technical file the way notified bodies expect.
MDR technical documentation structure
- Annex II
- Six sections: description, labelling, design and manufacturing, GSPR, risk, verification and validation
- Annex III
- PMS plan, PMCF plan, and a PMS report or PSUR
- Applies to
- Every device class, from class I to class III
- Format
- Clear, organised, readily searchable and unambiguous (Annex II introduction)
What Are the MDR Technical Documentation Requirements?
Article 10(4) of the MDR requires manufacturers to draw up and keep up to date technical documentation that allows the conformity of the device to be assessed. Annex II defines its content, and Annex III defines the post-market surveillance documentation that sits alongside it.
The medical device technical file requirements are the same for every class. What changes is the depth of evidence and who reviews it. A class I device follows the same Annex II structure as a class III implant, but with less testing and clinical data behind each section. See our guide to the types of MDR technical files for how the file changes by class and conformity route.
The MDR also requires the documentation to be presented in a clear, organised, readily searchable and unambiguous way. A consistent table of contents is the easiest way to meet that requirement and to help a notified body find evidence quickly. For the wider picture, including retention, language and notified body review, see our medical device technical documentation guide.
How Is MDR Technical Documentation Structured?
The MDR technical documentation structure follows the six numbered sections of Annex II, plus the Annex III post-market documents. Most manufacturers add a short introduction section at the front with the file details, manufacturer and notified body information.
Device description and specification
What the device is, who uses it, for which patients, and how it is classified.
Information supplied by the manufacturer
Labels and instructions for use.
Design and manufacturing information
Design stages, manufacturing processes, sites and suppliers.
General safety and performance requirements
How each Annex I requirement is met and which standards apply.
Benefit-risk analysis and risk management
Risk management file and the benefit-risk conclusion.
Product verification and validation
Pre-clinical and clinical data, plus information for specific device types.
Post-market surveillance documentation
PMS plan, PMCF plan, and the PMS report or PSUR.
MDR Annex II Technical Documentation: Table of Contents
The tables below map each technical file section to the Annex II clause it answers. The left column gives the Annex II reference, and the middle column gives a typical technical file section number.
Introduction (front matter)
Not required by a specific Annex II clause, but expected by most notified bodies as the entry point to the file.
| Annex II | Section | Content |
|---|---|---|
| – | 0.1 | Revision history |
| – | 0.2 | Purpose and scope of the technical file |
| – | 0.3 | Company profile, legal name and address of the manufacturer |
| – | 0.4 | EU authorised representative |
| – | 0.5 | Notified body |
Section 1: Device description and specification, including variants and accessories
Describes the device fully enough for an assessor to understand what it is, how it works and why it is classified the way it is.
| Annex II | Section | Content |
|---|---|---|
| 1.1(a) | 1.1.1 | Product or trade name |
| 1.1(a) | 1.1.2 | General description of the device |
| 1.1(a) | 1.1.3 | Intended purpose |
| 1.1(a) | 1.1.4 | Intended users |
| 1.1(b) | 1.1.5 | Basic UDI-DI (see UDI requirements) |
| 1.1(c) | 1.1.6 | Intended patient population |
| 1.1(c) | 1.1.7 | Medical conditions to be diagnosed, treated or monitored |
| 1.1(c) | 1.1.8 | Indications |
| 1.1(c) | 1.1.9 | Contraindications |
| 1.1(c) | 1.1.10 | Warnings |
| 1.1(d) | 1.1.11 | Principles of operation and mode of action |
| 1.1(e) | 1.1.12 | Rationale for qualifying the product as a medical device |
| 1.1(f) | 1.1.13 | Risk class and classification rule applied, with justification |
| 1.1(g) | 1.1.14 | Explanation of any novel features |
| 1.1(h) | 1.1.15 | Accessories and other devices or products used in combination |
| 1.1(i) | 1.1.16 | Configurations and variants |
| 1.1(j) | 1.1.17 | Key functional elements and components, with drawings |
| 1.1(k) | 1.1.18 | Raw materials, including those in contact with the body |
| 1.1(l) | 1.1.19 | Technical specifications of the device, variants and accessories |
| 1.2(a) | 1.2.1 | Overview of previous generations of the device |
| 1.2(b) | 1.2.2 | Overview of similar devices on the EU and international markets |
Section 2: Information to be supplied by the manufacturer
Every label and the instructions for use, in the languages accepted in the member states where the device is sold.
| Annex II | Section | Content |
|---|---|---|
| 2(a) | 2.1 | Labels on the device and its packaging (single unit, sales and transport packaging) |
| 2(b) | 2.2 | Instructions for use |
Section 3: Design and manufacturing information
Shows how the device was designed and how it is made consistently, including the sites and suppliers involved.
| Annex II | Section | Content |
|---|---|---|
| 3(a) | 3.1 | Design stages of the device |
| 3(b) | 3.2.1 | Manufacturing processes and their validation |
| 3(b) | 3.2.2 | Final product specification and testing |
| 3(b) | 3.2.3 | Manufacturing environmental controls and continuous monitoring |
| 3(c) | 3.3 | Sites, critical suppliers and subcontractors |
Section 4: General safety and performance requirements
Demonstrates conformity with each applicable general safety and performance requirement in Annex I, normally through a GSPR checklist.
| Annex II | Section | Content |
|---|---|---|
| 4(a), 4(b) | 4.1 | GSPR checklist: applicability and justification for each requirement |
| – | 4.2 | EU declaration of conformity |
| 4(c) | 4.3 | Applicable legislation |
| 4(c) | 4.4 | Applicable guidance documents |
| 4(c) | 4.5 | Harmonised standards and common specifications applied |
| 4(c), 4(d) | 4.6 | Other standards and solutions applied, with controlled document references |
Section 5: Benefit-risk analysis and risk management
Links the benefit-risk conclusion to the risk management file and the clinical evaluation. See our guide to medical device risk management.
| Annex II | Section | Content |
|---|---|---|
| 5(a) | 5.1 | Benefit-risk analysis (Annex I, sections 1 and 8) |
| 5(b) | 5.2 | Risk management solutions and results (Annex I, section 3) |
Section 6: Product verification and validation
Holds the test and clinical evidence, plus extra information for devices with specific characteristics.
| Annex II | Section | Content |
|---|---|---|
| 6.1(a) | 6.1.1 | Pre-clinical safety: engineering, laboratory and simulated-use tests |
| 6.1(b) | 6.1.2 | Biocompatibility |
| 6.1(b) | 6.1.3 | Electrical safety and electromagnetic compatibility |
| 6.1(b) | 6.1.4 | Software verification and validation |
| 6.1(b) | 6.1.5 | Sterilisation (see also 6.2(e)) |
| 6.1(b) | 6.1.6 | Stability and shelf life |
| 6.1(c) | 6.1.7 | Clinical evaluation report and updates, and clinical evaluation plan |
| 6.1(d) | 6.1.8 | PMCF plan and evaluation report, or justification if not applicable |
| 6.1(b) | 6.1.9 | Packaging, transport and performance during use |
| 6.2(a) | 6.2.1 | Medicinal substance within the meaning of Directive 2001/83/EC |
| 6.2(b) | 6.2.2 | Tissues or cells of human or animal origin, or their derivatives |
| 6.2(c) | 6.2.3 | Substances or combinations of substances absorbed by or dispersed in the body |
| 6.2(d) | 6.2.4 | CMR or endocrine-disrupting substances (Annex I, section 10.4) |
| 6.2(e) | 6.2.5 | Devices placed on the market sterile or in a defined microbiological condition |
| 6.2(f) | 6.2.6 | Devices with a measuring function |
| 6.2(g) | 6.2.7 | Devices connected to other devices: combination and compatibility |
| – | 6.3 | Manufacturer declaration and conclusion |
Section 7: Post-market surveillance documentation (Annex III)
Annex III sets out how the manufacturer will collect and act on real-world data once the device is on the market. It applies to every class and is reviewed together with the Annex II file.
| Annex III | Section | Content |
|---|---|---|
| 1.1 | 7.1 | Post-market surveillance plan (Article 84) |
| 1.1(a) | 7.2 | Collection of post-market information: incidents, complaints, field safety corrective actions, literature and similar devices |
| 1.1(b) | 7.3 | Methods for assessing data, trend reporting, indicators and thresholds, and communication with authorities |
| 1.1(b) | 7.4 | PMCF plan, or justification if PMCF is not applicable |
| 1.2 | 7.5 | PMS report (class I, Article 85) |
| 1.2 | 7.6 | Periodic safety update report (class IIa, IIb and III, Article 86) |
How Should You Organise MDR Technical File Contents?
- Follow the Annex II order. Notified bodies review files against Annex II, so the same numbering makes evidence easy to find.
- Reference, do not duplicate. Point to controlled test reports and records rather than copying their content into the summary.
- Keep the GSPR checklist central. Every applicable requirement should point to a specific document and revision.
- Keep it consistent. Intended purpose, indications, warnings and residual risks must read the same in the description, risk file, IFU and clinical evaluation.
- Control versions. Use a document index with revision numbers, and update it whenever the device or evidence changes.
To check an existing file against these requirements, use our MDR technical documentation checklist. To start from a ready-made structure, see our MDR technical file templates.
Need help meeting the MDR technical documentation requirements?
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MDR Technical Documentation Requirements: Common Questions
Which MDR annex defines the technical documentation content?
Annex II defines the technical documentation, and Annex III defines the technical documentation on post-market surveillance. Both are required for every device.
Do I have to use the Annex II numbering in my technical file?
The MDR does not require a specific numbering, but the file must be clear, organised and readily searchable. Following the Annex II order is the simplest way to meet that requirement.
Is the GSPR checklist part of the technical documentation?
Yes. Annex II section 4 requires a demonstration of conformity with the applicable general safety and performance requirements, which is normally presented as a GSPR checklist.
Is the clinical evaluation report part of the technical file?
Yes. Annex II section 6.1(c) requires the clinical evaluation report and its updates, together with the clinical evaluation plan.
What is the difference between a PMS report and a PSUR?
Class I devices need a PMS report, updated when necessary. Class IIa, IIb and III devices need a PSUR, updated at least every two years for class IIa and at least annually for class IIb and III.