What technical documentation does EU MDR require?
MDR Annex II · Annex III · Article 10(4)
The short answer
MDR requires two technical documentation components: Annex II (main technical file) and Annex III (post-market surveillance documentation). There is no prescribed format or template, but the content is strictly defined. Documentation must be available to competent authorities at all times, and must be retained for at least 10 years (15 years for implantable devices) after the last device was placed on the market.
Annex II — Main Technical Documentation
| Section | Key contents |
|---|---|
| 1. Device description and specification | Intended purpose, indications, contraindications, UDI, variants, accessories, predecessor devices, generation of device |
| 2. Information supplied by manufacturer | Label, IFU, promotional materials (Annex I Chapter III requirements) |
| 3. Design and manufacturing information | Design stages, manufacturing processes, materials, sterilisation, subcontractors |
| 4. GSPR checklist | General Safety and Performance Requirements from Annex I — all 23 requirements addressed with evidence references |
| 5. Benefit-risk analysis and risk management | ISO 14971 risk management file, benefit-risk determination, residual risk acceptability |
| 6. Verification and validation | Pre-clinical tests, software verification and validation, usability, biocompatibility, performance testing |
| 7. Clinical evaluation | CER per Annex XIV, clinical data summary, PMCF plan (or justification for no PMCF) |
Annex III — Post-Market Surveillance Documentation
- PMS Plan: How post-market data is collected, analysed, and actioned (required for all devices)
- PSUR (Periodic Safety Update Report): Mandatory for Class IIa, IIb, and III; Class IIb/III annually, Class IIa at least every 2 years
- PMS Report: Required for Class I devices; less detailed than PSUR
- PMCF Plan: Plan for proactive clinical data collection post-market
- PMCF Report: Results of PMCF activities; feeds into CER updates
The GSPR checklist explained
Annex I contains 23 General Safety and Performance Requirements. For each requirement, the technical documentation must state:
- Whether the requirement applies to this device (and justification if not applicable)
- How the requirement has been demonstrated to be met
- Which harmonised standard(s) or CS (Common Specification) were used
- Which evidence document in the technical file demonstrates compliance
The GSPR checklist is often the first document a Notified Body examiner reviews. Gaps here are a common trigger for follow-up questions and audit findings.
Common technical documentation gaps
- GSPR requirements not linked to specific evidence: Stating "meets requirement" without referencing the actual test report or standard
- Clinical Evaluation Report not current: CER must be updated regularly; a 3-year-old CER for a Class IIb device will be flagged
- Risk management not integrated: Risk file exists in isolation without feeding into software requirements, GSPR, and clinical evaluation
- Software documentation missing: IEC 62304 lifecycle records absent or not referenced in the technical file
- Labelling non-compliant: Missing MDR-mandated symbols, missing UDI, IFU not updated for MDR requirements
- PMS data not feeding back: PMS plan exists but complaint data, vigilance events, and literature surveillance are not informing benefit-risk updates
MDR technical documentation vs FDA Design History File
| EU MDR (Annex II/III) | FDA DHF (21 CFR 820.30) | |
|---|---|---|
| Structure | Annex II sections 1–7 + Annex III PMS | No prescribed structure; design controls outputs |
| Clinical evaluation | CER mandatory, continuous update required | 510(k)/PMA submission; less ongoing update requirement |
| Post-market component | Annex III — PSUR/PMS Report part of tech docs | MDR 803/806 reporting; separate from DHF |
| Retention | 10 years (15 years implantables) | 2 years after device discontinued, at minimum |
| Access requirement | Available to competent authorities at all times | Available to FDA upon request |
Frequently asked questions
How long must technical documentation be retained?
The Person Responsible for Regulatory Compliance (Article 15 MDR) is a named individual with documented qualifications who ensures MDR obligations are met. Required for all manufacturers; can be internal or external.
Can technical documentation be stored electronically?
Yes. Electronic documentation is acceptable provided it is accessible to competent authorities, has version control, and is protected from unauthorised changes. Document management system requirements are part of your QMS.
In which language must technical documentation be provided?
The Annex II/III technical file can be in any language agreed with the NB. However, the Declaration of Conformity must be in the official language(s) of the EU member state(s) where the device is sold. IFU language requirements depend on the target market(s).