GLOSSARYEU
MDR Annex II (Technical Documentation)
The content a manufacturer's technical documentation must include. The documentation has to be clear, organized, readily searchable, and unambiguous. It runs in six sections, from the device description to verification and validation.
Sections
- 1
- Device description and specification, including variants and accessories
- 2
- Information to be supplied by the manufacturer
- 3
- Design and manufacturing
- 4
- General safety and performance requirements
- 5
- Benefit-risk analysis and risk management
- 6
- Product verification and validation