General Safety and Performance Requirements
Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
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. They sit in Annex I of the MDR and IVDR, in three chapters: general requirements, design and manufacture, and information supplied with the device. Requirements that do not apply must be justified in the checklist.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
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.
Regulation (EU) 2017/745 governing medical devices in the European Union.
IVDR Essentials
· From this learning pathEU-designated organization that assesses conformity of medical devices under MDR and IVDR.
Mandatory European conformity mark for medical devices placed on the EU market.
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).
European Database on Medical Devices.
More in Regulatory
· Same categoryWhere this term appears across MedTech Terms.
- IVDR EssentialsLesson 6 of 13
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDR Annex ITier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.