General Safety and Performance Requirements (IVDR)
Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class.
Definition
Annex I sets out three chapters of General Safety and Performance Requirements. Chapter I covers general requirements including risk management (Section 3) and benefit-risk determination (Section 8). Chapter II covers requirements regarding performance, design, and manufacture (Sections 9 to 19), including analytical performance, clinical performance, chemical/physical/biological properties, sterility, protection against radiation, software, and devices with a measuring function. Chapter III covers requirements regarding the information supplied with the device (Section 20), including labelling and instructions for use.What this means in practice
The IVDR GSPR replaces the Essential Requirements of the old IVDD Annex I. Manufacturers demonstrate GSPR conformity through a GSPR checklist mapping each requirement to standards, common specifications, and internal evidence. Notified bodies review this checklist as part of technical documentation assessment.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
International standard for the application of risk management to medical devices.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Annex IVerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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