How do manufacturers demonstrate conformity with every applicable GSPR?

Manufacturers typically build a GSPR checklist mapping each applicable requirement in Annex I to the harmonised standards, Common Specifications, and internal verification or validation evidence that demonstrate compliance. Notified bodies review this checklist directly as part of technical documentation assessment for Class B, C, and D devices.

Is the IVDR GSPR the same as the old IVDD Essential Requirements?

The GSPR replaces the Essential Requirements from the IVDD Annex I, but it is structured differently and expanded, particularly around performance evaluation, software, and information requirements, so a straight one-to-one mapping from an old IVDD essential-requirements checklist is usually insufficient. Manufacturers transitioning legacy devices need to reassess against the current Annex I structure directly.

Do all GSPRs in Annex I apply to every device regardless of class?

Article 5(2) requires a device to meet the GSPRs in Annex I that apply to it, taking into account its intended purpose, meaning not every section is relevant to every device, for example sterility requirements only apply to devices supplied sterile. Manufacturers must document a rationale for any GSPR marked as not applicable.

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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.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

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 the regulation says

Article 5(2) states that a device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.

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.

Examples

A manufacturer developing a new in vitro diagnostic test for a specific disease must ensure its analytical sensitivity and specificity, as part of GSPR Chapter II on performance, are rigorously validated.
For an IVD instrument with integrated software, the manufacturer must address GSPR Chapter II requirements concerning software validation, cybersecurity, and data integrity to ensure safe and reliable operation.
The labelling and instructions for use for a point-of-care IVD test, detailed in GSPR Chapter III, must clearly communicate its intended use, performance characteristics, and any limitations to ensure safe and effective use by the end-user.

Common pitfalls

•A common mistake is treating the GSPR as a mere checklist exercise without genuinely integrating the requirements into the device's design, development, and risk management processes from the outset.
•Manufacturers often fail to adequately update their GSPR conformity assessment throughout the device's lifecycle, neglecting to account for post-market surveillance data, design changes, or evolving common specifications.
•Assuming that conformity to a single harmonized standard automatically proves GSPR compliance for a specific requirement is a pitfall; often, a combination of standards, common specifications, and internal evidence is needed, particularly for complex requirements.

Frequently asked questions

Annex I has three chapters: Chapter I covers general requirements including risk management and benefit-risk determination, Chapter II covers performance, design, and manufacture requirements such as analytical and clinical performance, chemical and biological properties, sterility, and software, and Chapter III covers information supplied with the device, including labelling and instructions for use.

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The lifecycle process defined by ISO 14971 for identifying, analyzing, evaluating, controlling, and monitoring risks associated with a medical device throughout its life cycle.

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Annex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class.

·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.

Remember this

Watch out: A common mistake is treating the GSPR as a mere checklist exercise without genuinely integrating the requirements into the device's design, development, and risk management processes from the outset.

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