General Safety and Performance Requirements (GSPR) are the set of mandatory safety and performance criteria in Annex I of the EU Medical Device Regulation (2017/745) that every medical device must meet before CE marking. They cover design safety, clinical performance, risk management, and the information supplied with the device.
What are General Safety and Performance Requirements (GSPR)?
General Safety and Performance Requirements (GSPR) sit in Annex I of EU MDR 2017/745. They define what a device has to achieve to be considered safe and to perform as intended across its service life. The in vitro diagnostic equivalent lives in Annex I of the IVDR (2017/746).
GSPR replaced the older “Essential Requirements” (ER) used under the Medical Device Directive. The change was not just a rename. The MDR list was expanded to address devices for lay users, IT security and cybersecurity, and products without an intended medical purpose. Manufacturers carry the burden of showing, with documented evidence, that every applicable requirement is satisfied.
Why General Safety and Performance Requirements (GSPR) Matter in Medical Device Development
Conformity with Annex I is a precondition for placing a device on the EU market. A Notified Body (for Class IIa and above) reviews the evidence behind each requirement during conformity assessment, and gaps stall certification.
The stakes are practical. Weak GSPR evidence is a common reason technical files get rejected or sent back with deficiencies, which adds months to a launch and burns engineering time. After market entry, the same requirements anchor audits and post-market reviews. A device whose GSPR conformity drifts out of step with the current state of the art can lose its certificate. For startups working on a funding runway, that delay is often the difference between hitting a milestone and missing it.
How General Safety and Performance Requirements (GSPR) Work
Annex I of the MDR contains 23 requirements organized into three chapters:
- Chapter I, General requirements (1 to 9). The foundational obligations: devices must perform as intended and must not compromise patient or user safety beyond an acceptable residual risk. This chapter mandates a risk management system, a benefit-risk judgment, and a fixed priority order for risk control: design out the hazard first, then add protective measures or alarms, then supply information for safety and training.
- Chapter II, Requirements regarding design and manufacture (10 to 22). The technical core. It covers chemical, physical, and biological properties (including biocompatibility), protection against infection and microbial contamination, devices incorporating a medicinal substance or materials of biological origin, software and programmable electronic systems, active devices, measuring functions, radiation protection, and mechanical and thermal risks.
- Chapter III, Information supplied with the device (23). The label and the instructions for use, including content, format, and language obligations.
Manufacturers demonstrate conformity through a GSPR checklist, usually a table that lists each requirement, marks it as applicable or not applicable with a justification, states the solution adopted, and cross-references the supporting evidence inside the technical documentation (Annex II). Where a harmonized standard exists and is cited in the EU Official Journal, applying it gives a presumption of conformity with the matching requirement under Article 8. That is the most efficient route, though many MDR requirements still lack a harmonized standard, so teams fill the gap with their own validated methods.
Common Challenges and Best Practices
The frequent failure is treating the checklist as a one-time formality. The GSPR matrix is a living document; it has to track changes in standards, the state of the art, and post-market findings. A second trap is marking requirements “not applicable” without a written rationale, which auditors read as an unexamined gap.
Traceability is where strong files separate from weak ones. Every “met” claim should point to a specific artifact: a test report, the risk management file under ISO 14971, biocompatibility data, the usability file, or the clinical evaluation. Build the matrix early and wire it into design controls so evidence accumulates as the project runs rather than being reconstructed at the end. Keep it synchronized with labeling and the IFU, since Chapter III claims fail when the documentation says one thing and the artwork says another.
How SJML Helps with General Safety and Performance Requirements (GSPR)
SJML supports GSPR conformity as part of its Compliance-as-a-Service work. The QARA team helps with regulatory strategy and device classification, and with building and maintaining the EU technical documentation, including the Annex I checklist and its evidence trail. Supporting capabilities sit in-house: risk management files aligned to ISO 14971, usability engineering, labeling and IFU support, clinical evaluation, and post-market surveillance planning. That lets the GSPR matrix stay connected to live design and quality records instead of becoming a standalone document.
Frequently Asked Questions
GSPR is the EU MDR successor to the Essential Requirements (ER) of the old Medical Device Directive. The structure is similar, but the GSPR list was expanded and tightened. It adds explicit obligations for devices used by laypersons, for IT security and cybersecurity, and for products without an intended medical purpose. Evidence expectations for risk management and clinical performance are also higher.
EU MDR Annex I contains 23 requirements, grouped into three chapters: general requirements (1 to 9), requirements regarding design and manufacture (10 to 22), and requirements regarding the information supplied with the device (23). Not every requirement applies to every device. The manufacturer assesses applicability per device and justifies any requirement marked not applicable.
Manufacturers prepare a GSPR checklist that maps each applicable requirement to the solution adopted and to the objective evidence supporting it, cross-referenced into the technical documentation. Applying a harmonized standard listed in the EU Official Journal gives a presumption of conformity for the matching requirement. A Notified Body reviews this evidence during conformity assessment for devices above Class I.
In vitro diagnostic devices follow their own General Safety and Performance Requirements set out in Annex I of the IVDR (2017/746), not the MDR. The concept is the same: a list of mandatory safety and performance criteria demonstrated through a checklist and supporting evidence. The specific requirements differ to reflect diagnostic risks such as analytical and clinical performance.
Related Terms
- EU MDR (EU 2017/745)
- Technical Documentation
- Harmonized Standard
- Risk Management File
- CE Marking
