IVDR

IVDR stands for the In Vitro Diagnostic Regulation, the European Union regulation (EU) 2017/746 that governs the safety and performance of in vitro diagnostic medical devices. It replaced the IVD Directive (98/79/EC) and aims to increase patient safety, transparency, and market oversight through strengthened clinical evidence, post-market surveillance, and regulatory rigor.

Scope and devices covered: The IVDR applies to in vitro diagnostics used to examine samples derived from the human body, including reagents, instruments, software, calibrators, control materials, and companion diagnostics. It covers devices intended for diagnosing, preventing, monitoring, or predicting disease, and it extends to software and interpreters used in diagnostic decision-making. Some items used for basic research or certain in-house devices (manufactured and used within a health institution) are treated under specific rules.

Classification and conformity: IVDs are classified from A to D based on risk, with D being the highest risk. Higher-risk devices face more stringent conformity assessment procedures and documentation requirements. Most IVDs require a conformity assessment by a Notified Body, which involves review of technical documentation, risk management, quality management system compliance, and, for higher classes, clinical evidence. Some lower-risk class A devices may be eligible for self-declaration, depending on circumstances.

Clinical evidence and performance: The IVDR emphasizes clinical evidence and performance evaluation. Manufacturers must demonstrate analytical and clinical performance, validate intended use, and maintain ongoing evidence through post-market surveillance and periodic updates.

Post-market and transparency: The regulation introduces enhanced post-market controls, vigilance reporting, and field safety actions. It requires registration of devices and certain economic operators in the Eudamed database and the use of Unique Device Identification (UDI) to improve traceability and transparency.

In-house devices and transitional aspects: Article 5 governs health-institution–made devices used within the same organization. The IVDR also provides transitional provisions and timelines to complete conformity and market registration.