IVDRi

IVDRi (In Vitro Diagnostics Regulatory Information) is a term used in regulatory technology discourse to describe a proposed digital framework for managing and exchanging regulatory data for in vitro diagnostic devices. The concept envisions a centralized, machine-readable registry that would house device classification, conformity assessment evidence, performance and clinical data, labeling, post-market surveillance records, and lifecycle updates. By standardizing data models and access protocols, IVDRi would aim to streamline regulatory workflows, improve traceability, and reduce duplication of audits across jurisdictions.

Background and rationale: The growing complexity of in vitro diagnostics, combined with evolving national and regional requirements, has driven interest in more interoperable regulatory information systems. IVDRi is commonly discussed as a means to support lifecycle regulatory compliance from development through post-market monitoring, enabling automated checks, easier validation of changes, and faster information retrieval for authorities, manufacturers, and notified bodies.

Structure and components: Proposals generally envision core data modules (product and device identifiers, classification, technical documentation, risk management, clinical evidence, labeling), a standardized data model, version control with audit trails, access governance, and APIs or data exchange formats for cross-border use. Governance would involve alignment with existing standards and regulator guidance.

Status and reception: IVDRi is not an official regulatory program. It appears in industry white papers, academic articles, and pilot studies as a concept to inform future harmonization efforts. Supporters emphasize efficiency and transparency; critics caution about governance, privacy, funding, and interoperability barriers.

See also: In vitro diagnostic regulation, regulatory information management, regulatory technology, data standards.