RegulationIllustrative imageIn Vitro Diagnostic Regulation (IVDR)
Sets the risk-based framework for in-vitro diagnostic devices, with four classes, performance evaluation requirements and a substantially expanded role for notified bodies.
IVDs are classified into classes A to D according to the risk to the individual and to public health, as defined in Annex VIII. Class D covers the highest-risk assays, including blood grouping and detection of lethal transmissible agents, and requires notified body assessment plus reference laboratory involvement.
The regulation requires a performance evaluation that demonstrates scientific validity, analytical performance and clinical performance. Manufacturers must document the intended use precisely, since a change in claimed use can alter both the class and the evidence required.
Post-market performance follow-up is a distinct obligation for IVDs, and the performance evaluation report must be updated with data gathered after placing the device on the market. Companion diagnostics additionally require consultation with a medicinal product authority.
Devices manufactured and used within a single health institution may fall outside the regulation where the conditions in Article 5(5) are met, including appropriate quality management and a justification that no equivalent CE-marked device is available on the market.
Important: this page is an editorial summary for demonstration purposes. It is not legal advice and does not replace the official text. Always rely on the consolidated version published in the Official Journal of the EU and on qualified regulatory advice.