In-house IVD

Many hospital laboratory tests rely on this exemption. The conditions include a quality management system and a justification that no equivalent CE marked device meets the patients' needs.

An IVD that is manufactured and used only within a health institution established in the Union and that meets all conditions set in Article 5(5) of the IVDR (per MDCG 2023-1)

MDCG 2026-6, Section 1, Abbreviations and terminology

An IVD manufactured and used within the same health institution as outlined in IVDR Article 5(5). Health institution is defined in IVDR Article 2(29).

MDCG 2024-4, Section 4.8