Framework
EUIVDR — General Safety and Performance Requirements
Annex I of the EU IVDR 2017/746 establishes the General Safety and Performance Requirements (GSPRs) that all IVD medical devices must meet. These requirements cover fundamental safety principles, design and manufacturing requirements, performance and analytical requirements specific to IVD devices, and information requirements. Compliance with GSPRs is the foundation of the conformity assessment process for IVD devices.
Overview
Background
The General Safety and Performance Requirements for IVD devices replaced the Essential Requirements of the former IVD Directive (98/79/EC). Under Regulation (EU) 2017/746, the GSPRs were significantly expanded to include IVD-specific performance requirements, cybersecurity considerations, and updated safety expectations, reflecting the evolving technological landscape and the critical role of IVD devices in clinical decision-making.
Applicability
The GSPRs apply to all IVD medical devices placed on the EU market, regardless of risk classification. Manufacturers must demonstrate compliance with all applicable GSPRs through their technical documentation. Notified bodies evaluate GSPR compliance as part of the conformity assessment process for Class B, C, and D devices. The requirements are organized into general requirements (Chapter I), design and manufacture requirements (Chapter II), and information requirements (Chapter III).