Framework
EUIVDR — Special Devices
The EU IVDR 2017/746 establishes specific provisions for certain categories of IVD medical devices that require additional or adapted requirements. These include companion diagnostics, devices for self-testing, devices for near-patient testing, and devices manufactured and used within health institutions, each subject to tailored regulatory requirements reflecting their unique risk profiles and use contexts.
Overview
Background
Under Regulation (EU) 2017/746, the European Union introduced specific provisions for IVD device categories that present unique regulatory challenges. These requirements address the distinct safety considerations of companion diagnostics, the unique use environment of self-testing and near-patient testing devices, and the regulatory status of in-house IVDs manufactured by health institutions.
Applicability
These provisions apply to manufacturers of IVD devices that fall into specific categories defined by the IVDR. Companion diagnostics are linked to specific medicinal products and require coordination with pharmaceutical regulatory processes. Self-testing devices must be suitable for use by lay persons. Near-patient testing devices must perform reliably outside laboratory settings. Health institution-manufactured devices must comply with specific conditions.