GSPR Checklist & General Safety Performance Requirements Support

A GSPR checklist is a structured matrix used under EU MDR Annex I to show how a medical device meets each applicable General Safety and Performance Requirement. It identifies whether a requirement applies, explains the method of conformity, and links to supporting evidence such as harmonized standards, test reports, risk management documents, labeling, clinical evaluation, and post-market records.

GSPR stands for General Safety and Performance Requirements. These are the core safety, design, manufacturing, labeling, usability, and performance obligations set out in Annex I of EU MDR 2017/745. Manufacturers must assess each requirement for applicability and demonstrate conformity with objective evidence in their technical documentation to support CE marking and Notified Body review.

Any manufacturer preparing technical documentation for a medical device under EU MDR needs a GSPR checklist. It is especially important for CE marking submissions, legacy device transitions, significant changes, and Notified Body reviews. The checklist helps demonstrate that Annex I requirements have been systematically assessed and supported with traceable evidence across the technical file.

A well-built GSPR checklist usually references harmonized standards, common specifications, verification and validation reports, biocompatibility data, software documentation, clinical evaluation reports, risk management files, PMS or PMCF records, labeling, and IFUs. The goal is to show exactly where conformity evidence exists and ensure each reference is current, relevant, and consistent with the device’s intended use.

A simple compliance checklist often lists requirements without proving conformity. A proper GSPR checklist is evidence-based and device-specific. It evaluates applicability, explains the rationale for conformity, and links each requirement to supporting documentation. That level of traceability is what Notified Bodies expect when reviewing EU MDR technical files, especially for higher-risk or more complex devices.

Not always. Harmonized standards are important because they provide a recognized route to demonstrating conformity, but they do not replace the need for device-specific evidence. Manufacturers still need to show how standards were applied, where test results support compliance, and how risk management, labeling, clinical evidence, and post-market data collectively address the applicable GSPR requirements.

Common issues include missing applicability rationales, outdated standard references, weak links to supporting evidence, inconsistent terminology across documents, and gaps between the GSPR matrix and risk management or clinical evaluation files. Another frequent problem is citing documents that exist but do not fully support the claim being made. These weaknesses often trigger Notified Body questions and remediation work.

A GSPR checklist should be updated whenever there is a significant design change, labeling revision, new test data, updated clinical evidence, revised standards, or changes to post-market findings that affect safety or performance claims. It should also be reviewed before Notified Body submission, surveillance activities, or technical documentation updates to ensure all references remain accurate and defensible.