General Safety and Performance Requirements (GSPR)

What are the EU MDR General Safety and Performance Requirements?

The General Safety and Performance Requirements, commonly called the GSPR, are the requirements in Annex I of the EU Medical Device Regulation. A device must meet the requirements that apply to it before it can be placed on the EU market under the MDR.

Annex I covers three broad areas: general requirements, requirements regarding design and manufacture, and information supplied with the device. Topics include risk management, chemical and biological properties, infection control, mechanical and electrical risks, software, labeling and instructions for use.

Does every GSPR apply to every medical device?

No. Applicability depends on the device’s intended purpose, design, materials, operating principles, users and use environment. A manufacturer should assess every Annex I requirement, identify the applicable requirements and explain why any requirement is not applicable.

This assessment is often recorded in a GSPR checklist or matrix. Treating requirements as “not applicable” without a device-specific rationale can leave a gap in the technical documentation.

What should a GSPR checklist contain?

A useful checklist identifies each applicable requirement, the method used to demonstrate conformity and the controlled evidence supporting the conclusion. Evidence can include risk-management records, test reports, clinical evidence, design verification, validation, labeling and applicable standards.

Annex II, Section 4 requires the technical documentation to identify the standards, common specifications or other solutions used and to cross-reference the location of supporting evidence. A checklist is therefore an evidence map, not a stand-alone declaration that the device complies.

Do harmonized standards make a device compliant with the GSPR?

Compliance with applicable harmonized standards, or relevant parts, whose references are published in the Official Journal of the European Union confers a presumption of conformity with the MDR requirements those standards cover. It does not establish conformity with requirements outside that scope or replace the manufacturer’s device-specific assessment. The manufacturer must confirm that the standard is applicable, use the correct edition and address any requirement not fully covered by the standard.

Clinical evaluation is also part of demonstrating conformity where clinical data are needed. See our EU MDR consulting overview and Clinical Evaluation Report services for the connected evidence requirements.

How are the GSPR connected to CE marking?

The GSPR assessment forms part of the device’s technical documentation and conformity assessment. Once the applicable MDR requirements have been demonstrated and the required conformity assessment is complete, the manufacturer can draw up the EU Declaration of Conformity and affix the CE mark. Learn more in our EU MDR CE marking guide.