Glossary · EU medical devices: MDR
Technical documentation (MDR and IVDR)
Also known as: Technical documentation (MDR), Technical documentation (IVDR), Annex II documentation
Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, technical documentation is the set of documents the manufacturer draws up and keeps up to date to show that a device conforms to the regulation. Annex II lists its content; Annex III sets out the technical documentation on post-market surveillance.
- EU
- MDR
- IVDR
- Technical documentation
In one sentence
MDR and IVDR technical documentation (Annexes II and III) is the manufacturer’s evidence that a device conforms, kept up to date across its lifecycle.
Example
A manufacturer of an ultrasound system structures its technical documentation by Annex II headings, links the GSPR checklist to test reports and the clinical evaluation report, and adds the PMS plan and PSURs as its Annex III part.
How it applies
- Annex II content: Device description and specification, including variants and accessories; information to be supplied by the manufacturer (label and IFU); design and manufacturing information; the GSPR checklist; the benefit-risk analysis and risk management; and product verification and validation, including preclinical and clinical data.
- Annex III content: The post-market surveillance plan and the resulting reports, such as the PMS report or PSUR; see post-market surveillance.
- Clear and searchable: Annex II asks for documentation presented in a clear, organized, readily searchable and unambiguous manner. Notified bodies assess it; competent authorities can request it.
- Kept current: The documentation follows the device through design changes, PMS findings and new standards. Manufacturers keep it available to authorities for a set period after the last device is placed on the market (longer for implantables).
- AI: For AI-based devices, the AI Act allows a single set of technical documentation that also covers the information required for high-risk AI systems.
- Technical documentation: Treat it as a set of controlled documents under change control, with traceability from requirement to evidence; a notified body judges the evidence, not the length of the file.
MDR technical documentation vs. the generic term
The general term technical documentation covers any product documentation; in machinery practice the regulatory set is often called the technical file. Under MDR and IVDR the content is fixed by Annexes II and III, and the post-market part is a formal, separate element.