Annex II · Annex III
MDR technical documentation under Annex II and Annex III
MDR technical documentation is the set of documents a manufacturer must draw up and keep up to date to show that a device conforms to Regulation (EU) 2017/745. Annex II lists the content: device description and specification, information supplied by the manufacturer, design and manufacturing information, the GSPR, benefit-risk analysis and risk management, and product verification and validation. Annex III adds the technical documentation on post-market surveillance: the PMS plan and the PSUR or PMS report. This page maps each part to the place it lives in MDRpilot.
Who it is for
- Teams who need to know what goes into each section
- Manufacturers checking a legacy file against MDR
- Reviewers preparing an internal pre-submission check
Key capabilities
Section map
Annex II and III sections with status, so missing parts are listed rather than discovered.
Classification rationale
The Annex VIII assistant stores the rule and reasoning on the product, ready for section II.1.
Verification evidence
Test reports are read for a pass or fail verdict; passing reports can verify risk controls and support GSPR rows.
PMS documentation
Annex III documents are part of the same product record.
Annex II and III section by section
| Annex section | Content and where it lives in MDRpilot |
|---|---|
| II.1 Device description and specification | Intended purpose, users, principles of operation, variants, accessories, classification rationale, Basic UDI-DI. Product record and Annex VIII assistant. |
| II.2 Information supplied by the manufacturer | Labels and IFU in the languages of the target markets. IFU module and label export. |
| II.3 Design and manufacturing information | Design stages, manufacturing processes and their validation, sites and critical suppliers. Technical file section, design control records, supplier evaluation. |
| II.4 General safety and performance requirements | Applicability of each Annex I requirement, justification, methods, standards and evidence. GSPR module. |
| II.5 Benefit-risk analysis and risk management | Benefit-risk analysis under Annex I Sections 1 and 8 and the risk management solutions under Section 3. ISO 14971 risk file. |
| II.6 Product verification and validation | Pre-clinical tests (biocompatibility, electrical safety, software, stability, packaging, sterilisation) and the clinical evaluation. Evidence files and clinical module. |
| III PMS plan | Data collection, indicators and thresholds, complaint and trend handling, PMCF. PMS module. |
| III PSUR or PMS report | Periodic summary of post-market data and conclusions. PSUR/PMS report outline by class. |
Common weaknesses reviewers find
Each of these is a cross-reference problem. MDRpilot reduces them by drawing the device description from one record, by linking evidence to GSPR rows and risk controls, and by flagging dependent documents when the product data changes.
- Device description and IFU describe different intended purposes or user groups
- GSPR rows marked applicable with a standard listed but no test report attached
- Risk controls without evidence that the control was verified
- Clinical evaluation that does not cover every indication claimed in the IFU
- PMS plan with no measurable indicators or thresholds
How the workflow runs
- 1
Start from the product
Complete the device description once.
- 2
Work Annex I
Decide applicability and methods for each GSPR.
- 3
Attach evidence
Upload verification and validation reports and confirm links.
- 4
Complete Annex III
Write the PMS plan and schedule the PSUR or PMS report.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- This map follows the MDR text. Device-specific requirements such as those for software, devices with a medicinal substance or devices made with animal tissue need additional sections that your team must define.
- MDRpilot does not decide grouping of devices or applicability of requirements; it records your decisions and their justification.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
What is the difference between Annex II and Annex III?
Annex II covers the technical documentation of the device itself. Annex III covers the technical documentation on post-market surveillance, namely the PMS plan and the PSUR or PMS report.
Is the technical documentation the same as the design history file?
No. The design history file is a design control record. The MDR technical documentation draws on it, especially in section II.3 and II.6, but has a wider scope.
Must the technical documentation be in a specific language?
The language is agreed with the notified body and must be acceptable to it. Labels and IFU must be in the languages required by the Member States where the device is made available.
How often must the technical documentation be updated?
Article 10 requires it to be kept up to date. Updates follow design changes, new standards, PMS findings and clinical evaluation updates.
Can MDRpilot check my Annex II file for gaps?
Yes. Section status, GSPR evidence links and the readiness view show where content or evidence is missing. Whether the content is adequate remains a judgement for your team and your notified body.
Related workflows
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- PMS and PMCF software that feeds back into risk and clinical evaluationPost-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.Read more
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
Guides and resources
- MDR Annex II and Annex III ExplainedSection-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.Read more
- EU MDR Technical Documentation: Complete GuideWhat EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.Read more
- What Is GSPR Compliance?What the General Safety and Performance Requirements are, how Annex I is organised, how to document GSPR compliance and the mistakes reviewers find most often.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
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