Regulatory
Technical Documentation
In one line
The dossier of design, manufacturing, risk, and clinical/performance evidence a manufacturer compiles under MDR/IVDR Annexes II and III to demonstrate conformity.
Definition
Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), technical documentation is the complete evidence file a manufacturer must draw up and keep up to date before placing a device on the market. Annex II requires device description and specification, information supplied by the manufacturer, design and manufacturing information, general safety and performance requirements (GSPR) documentation, benefit-risk analysis and risk management, and product verification and validation data including clinical or performance evaluation. Annex III adds post-market surveillance documentation: the PMS plan, PMS report or periodic safety update report (PSUR), and vigilance data. Notified bodies assess technical documentation directly (Class III, implantables, Class D) or by representative sampling (Class IIa, IIb, most Class B/C IVDs) as part of conformity assessment.
Why it matters
Technical documentation is a living file, not a one-time submission. It must be maintained for at least 10 years after the last device is placed on the market (15 years for implantables) and be available to competent authorities on request. In the US FDA system, the closest functional equivalent is the Design History File under 21 CFR 820.30(j), but the DHF is narrower: it documents that the design was developed per the design control procedure, whereas MDR/IVDR technical documentation additionally bundles GSPR conformity, clinical/performance evidence, and PMS in one structured Annex II/III set.
Common pitfalls
- •Treating technical documentation as a static submission artifact rather than a document set that must be revised whenever design, intended purpose, or risk classification changes.
- •Organizing content by internal department instead of the Annex II/III structure, which slows notified body review and increases the risk of non-conformities during audits.
- •Omitting the Annex III post-market surveillance report or PSUR, assuming Annex II design evidence alone satisfies the regulation.
Sources