Regulation IVDR 2017/746
Regulation IVDR 2017/746 – Regulation IVDR 2017/746 is a key legislative act concerning in vitro diagnostic medical devices in the European Union (EU). It was developed to replace the previous Directive on in vitro diagnostic medical devices 98/79/EEC.
Unlike the previous regulation, IVDR introduces a number of new requirements for the circulation of in vitro diagnostic medical devices within the European Union:
Classification of in vitro diagnostic medical devices: Establishes new classification rules for IVDs based on their intended use and risk to patients. These rules completely replace the previous classification system. In vitro diagnostic devices are now divided into 5 classes: A, B, C, and D. Many devices that previously did not require involvement of a notified body now require certification with their participation. For example, COVID-19 tests, which previously underwent self-declaration conformity assessment, are now classified as the highest risk class – Class D.
Additional labeling and traceability requirements: The IVDR mandates additional identification of in vitro diagnostic devices using a unique device identifier (UDI) that must be applied to each batch of released devices.
EUDAMED Database: Introduction of a European database for enhanced traceability. EUDAMED is a centralized system developed by the European Commission for information exchange and coordination regarding medical devices in the EU. It contains data on medical devices, manufacturers, distributors, authorized representatives, clinical studies, and incident reports. The EUDAMED database enhances transparency, safety, and effectiveness of medical devices in the European market.
Post-marketing surveillance: A new requirement under IVDR is the need for post-market performance monitoring to update performance assessments as needed throughout the device’s lifecycle.
Enhanced market surveillance and unannounced inspections: IVDR provides for increased oversight by national authorities and the European Commission to ensure compliance with established requirements.