EU IVDR — In Vitro Diagnostic Regulation (EU) 2017/746 — Official Full Text

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

Overview

The IVDR replaces the previous In Vitro Diagnostic Medical Devices Directive (98/79/EC) with a significantly strengthened regulatory framework for IVD devices in the EU. It introduces a new risk-based classification system (Classes A, B, C, D) requiring substantially more devices to undergo Notified Body review. The regulation enhances requirements for clinical evidence (performance evaluation), post-market surveillance, and transparency.

Key Areas

• Risk-based classification of IVDs (Classes A, B, C, D)
• Performance evaluation and clinical evidence requirements
• Conformity assessment and Notified Body involvement
• Companion diagnostics requirements
• Post-market surveillance and performance follow-up (PMPF)
• Vigilance and incident reporting
• UDI system for IVDs
• EUDAMED integration
• EU Reference Laboratories
• Technical documentation and labelling requirements
• In-house device requirements

Key Dates

• Published: 5 May 2017 (Official Journal L 117)
• Date of Application: 26 May 2022
• Replaces: Directive 98/79/EC (IVDD)