Framework
EUIVDR — Technical Documentation
The EU IVDR 2017/746 Technical Documentation requirements define the comprehensive documentation package that manufacturers must compile and maintain for in vitro diagnostic (IVD) medical devices. Covering Annexes II and III of the regulation, these requirements specify the device description, design and manufacturing information, safety and performance data, benefit-risk analysis, and product verification and validation evidence specific to IVD devices.
Overview
Background
Established under Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation replaced the former IVD Directive (98/79/EC). The technical documentation requirements are substantially more detailed, reflecting the shift from a self-certification model for most IVDs to a risk-based classification system with greater notified body involvement and documentation scrutiny.
Applicability
These requirements apply to all manufacturers placing IVD medical devices on the EU market, regardless of device risk class. The technical documentation must demonstrate compliance with the General Safety and Performance Requirements and must be maintained throughout the device lifecycle. It is reviewed by notified bodies during conformity assessment for Class B, C, and D devices.