GSPR (general safety and performance requirements)

The General Safety and Performance Requirements are the checklist in Annex I of the EU MDR that a device must meet to be placed on the Union market.

Annex I is organized into general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device. For each applicable requirement the technical documentation explains how it is met, with standards, test evidence, or a justification that it does not apply. That explanation is often called a GSPR checklist, and it is part of the technical documentation in Annex II.

Standards such as ISO 13485, ISO 14971 and product-specific standards are ways to demonstrate parts of the GSPRs. They are not a substitute for walking Annex I. A requirement you marked 'not applicable' without a reason is a frequent technical-file gap.

HAVGATE does not ship a GSPR authoring wizard. Your controlled list of applicable requirements can live with your technical-documentation procedure in document control, and internal audits can sample whether the checklist matches the device you actually sell.