Technical documentation for medical devices (MDR and ISO 13485)
Technical documentation is the product file that proves a medical device is safe and effective. The EU MDR 2017/745 sets out exactly what it must contain in Annexes II and III. ISO 13485 determines how you manage that file: version control, approvals, archiving and change control. You need both. The MDR says what is in it, and ISO 13485 ensures you keep it up to date.
The relationship is direct: your quality system is the factory, and your technical documentation is the product that comes off the line. A well-managed QMS makes it demonstrable that every product file is current, complete and traceable. Also read the page MDR and ISO 13485 for the wider context.
Technical documentation must be kept for at least 10 years after the last day of production (15 years for implantable devices). This is an MDR requirement, not an ISO requirement.
What must be in the technical documentation? (MDR Annex II)
| Component | What it contains |
|---|---|
| Device description and specifications | Description, intended use, user group, indications, contraindications |
| Labelling and instructions for use | All physical and digital labels, IFU (Instructions for Use) |
| Design and manufacturing information | Drawings, specifications, processes, raw materials, qualifications |
| Risk management | Complete risk management file in line with ISO 14971:2019 |
| Verification and validation | Test and validation reports, software validation, clinical evaluation |
| Clinical evaluation | Systematic literature review, clinical data, PMCF plan |
| Post-market surveillance (PMS) | PMS plan, PMCF reports, vigilance records |
| GSPR compliance | Demonstrable compliance with the General Safety and Performance Requirements (MDR Annex I) |
| UDI information | Unique Device Identification code per product variant |
The role of ISO 13485 in technical documentation
ISO 13485 does not dictate what goes into a product file. It sets out how you manage it. The standard sets requirements for:
- Document control (clauses 4.2.4 and 4.2.5): current versions, approval workflow, archiving.
- Design controls (clause 7.3): every design and validation record is part of the technical file.
- Change control: every product change must leave a controlled trail.
- Supplier control (clause 7.4): supplier documents form part of your technical file where they affect product specifications.
This is how it works in practice. Suppose a component changes supplier. ISO 13485 requires an approved change record. The MDR requires that the change is reflected in your technical documentation and, depending on the risk class, sometimes reassessed by the notified body.
Many companies keep technical documentation separate from their QMS. This leads to version conflicts: your procedure says one thing and your product file says another. Auditors spot this quickly.
EUDAMED and your technical documentation
EUDAMED is the European database for medical devices. The first four modules become mandatory in 2026. Relevant to your technical documentation:
- You register your product in EUDAMED with product information and UDI.
- Certificates issued by your notified body are added to EUDAMED automatically.
- For a recall or Field Safety Corrective Action (FSCA), you also register this in EUDAMED.
ISO 13485 does not regulate EUDAMED registration directly, but your traceability processes (UDI linking, CAPA administration) make timely and correct registration possible. See also CAPA under ISO 13485 for the link with FSCAs.
Technical documentation in the ISO 13485 audit
In an ISO 13485 audit, the auditor reviews document management, not the product file itself (that is reserved for the notified body). The typical audit questions are:
| Audit question | What it is about |
|---|---|
| Are documents approved at their current version? | The document control process works |
| Is a change log kept? | Traceability of product evolution |
| Are validation reports available as records? | Evidence for design control |
| Are supplier files updated after a supplier change? | Supplier control is applied consistently |
Read more about how auditors test this in the ISO 13485 audit process.