Framework
EUMDR — General Safety and Performance Requirements
Annex I of the EU MDR 2017/745 establishes the General Safety and Performance Requirements (GSPRs) that all medical devices must meet. These requirements cover fundamental safety principles, design and manufacturing requirements, information requirements, and specific requirements for particular device types. Compliance with GSPRs is the foundation of the conformity assessment process.
Overview
Background
The General Safety and Performance Requirements replaced the Essential Requirements of the former Medical Devices Directive (93/42/EEC). Under Regulation (EU) 2017/745, the GSPRs were significantly expanded and updated to reflect current technological capabilities, clinical evidence standards, and safety expectations. They serve as the primary benchmark against which device safety and performance is evaluated.
Applicability
The GSPRs apply to all medical devices placed on the EU market, regardless of risk classification. Manufacturers must demonstrate compliance with all applicable GSPRs for their specific device through their technical documentation. Notified bodies evaluate GSPR compliance as part of the conformity assessment process. The requirements are organized into general requirements (Chapter I), design and manufacture requirements (Chapter II), and information requirements (Chapter III).