All terms
General Safety and Performance Requirements
Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
GSPRs replace the old Essential Requirements of MDD/IVDD. Manufacturers prepare a GSPR checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity. What the regulation says
Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), manufacturers must demonstrate conformity with the General Safety and Performance Requirements (GSPR) set out in Annex I of each regulation. This demonstration is a prerequisite for CE marking and placing a device on the European market, as outlined in Article 48 of the MDR. Regulators expect manufacturers to compile and maintain technical documentation, including a GSPR checklist, to prove compliance throughout the device lifecycle.What this means in practice
The GSPR checklist is the spine of the EU technical documentation and one of the first things a Notified Body audits.Examples
- A manufacturer of a new blood glucose meter must document how the device meets GSPR 12.2 on accuracy and GSPR 17.1 on software validation, providing specific test reports and risk analysis outputs.
- For a surgical robot, compliance with GSPR 14.1 on human factors and GSPR 16.1 on cybersecurity must be detailed, including usability studies and penetration test reports.
- An in vitro diagnostic test kit
Common pitfalls
- •A common pitfall is failing to provide specific, traceable evidence for each GSPR, relying instead on general statements of compliance.
- •Manufacturers often struggle to adequately address cybersecurity and data protection GSPRs, which require specialized expertise and detailed documentation.
- •Another mistake is treating the GSPR checklist as a one-time activity rather than a living document that is updated throughout the device's lifecycle.
- •Failing to link GSPR compliance to risk management outputs can lead to gaps in addressing potential harms and vulnerabilities.
- •Incorrectly interpreting the scope and intent of certain GSPRs can result in inadequate technical solutions and non-compliance discoveries during audits.
Frequently asked questions
The primary purpose of the GSPRs is to establish fundamental safety and performance benchmarks that medical devices and in vitro diagnostic devices must meet to protect patients, users, and other persons, while achieving their intended purpose.
Related terms
Shared paths + categoryRegulatory
EU In Vitro Diagnostic Regulation(IVDR)
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
IVDR Essentials
Regulatory
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
Same category
Regulatory
Notified Body(NB)
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
IVDR Essentials · adjacent
Regulatory
CE Mark
Mandatory European conformity mark for medical devices placed on the EU market.
IVDR Essentials
Clinical & Trials
Clinical Evaluation Plan(CEP)
EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
IVDR Essentials · adjacent
Regulatory
EUDAMED
European Database on Medical Devices.
IVDR Essentials
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1IMDRF·1RAPS·1
- 1MDR Annex IVerifiedEUR-Lexeur-lex.europa.eu
- 2IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusVerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.