Glossary Term
EU IVDR
Definition
The EU IVDR (Regulation (EU) 2017/746) is the regulatory framework governing the safety, performance, and quality of in vitro diagnostic (IVD) medical devices in the European Union. It replaced the previous In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) and introduced more stringent requirements for device classification, clinical evidence, post-market surveillance, and conformity assessments.
Relevance to the MedTech Industry
The EU IVDR ensures that IVD devices used for disease diagnosis, patient monitoring, and health screening meet high safety and performance standards. It emphasizes transparency, traceability, and scientific rigor to protect patient health and improve public trust in diagnostic technologies.
Additional Information & Related Terms
Key Components of the EU IVDR
Risk-Based Classification
Devices are classified from Class A (low risk) to Class D (high risk), with higher classes requiring Notified Body oversight.
Performance Evaluation
Includes scientific validity, analytical performance, and clinical performance to ensure safety and efficacy.
Unique Device Identification (UDI)
Mandates traceability of devices through UDI systems to enhance supply chain transparency.
Post-Market Surveillance (PMS)
Requires continuous monitoring of device performance and regular reporting to maintain compliance.
Related Terms
EU MDR A parallel regulation governing non-IVD medical devices in the EU.
Notified Body Independent organizations designated to assess conformity under the IVDR.
Post-Market Surveillance (PMS) A critical component for monitoring device performance after market release.
ISO 13485 The quality management standard often required under the IVDR for manufacturers.