Knowledge · Technical documentation
Technical documentation under EU MDR
Structure per Annexes II and III — the evidence every notified body checks first.
The technical documentation is the central conformity evidence of a medical device: it demonstrates over the whole lifecycle that the device meets the general safety and performance requirements of the EU MDR. Structure and content are defined in Annex II (documentation structure) and Annex III (post-market surveillance documentation).
Core contents per Annex II
- Device description and variants, intended purpose
- Risk management and benefit-risk analysis
- Product design: specifications, materials, verification
- Clinical evaluation and clinical data
- Labelling and instructions for use (IFU)
- Manufacturing: processes, validation, sterilisation (if applicable)
- References to standards, e.g. EN ISO 15223-1:2021 for symbols
Lifecycle and PMS
The technical documentation is a living system: post-market surveillance, PMCF plans and vigilance feed insights back; documentation must be kept current as long as the device is on the market.
Frequently asked questions
How long must the technical documentation be kept?
At least 10 years after the last device was placed on the market, for class III 15 years — per MDR Article 10(8).
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.