Summary of Safety and Performance (IVDR)
Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED.
Definition
Article 29 of the IVDR requires manufacturers of Class C and D devices (except performance studies) to draw up a Summary of Safety and Performance. The SSP is written in a way clearly understood by the intended user and, where relevant, the patient, is validated by the notified body, and is made available to the public through EUDAMED.What this means in practice
The SSP is the IVDR counterpart of the MDR SSCP. It plays an important transparency role: hospitals, laboratories, and patients can review claimed performance and post-market findings for high-risk IVDs without accessing the technical file.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
European Database on Medical Devices.
Public-facing summary required for high-risk and implantable devices under EU MDR.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Article 29VerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2022-9 SSP GuidanceUncheckedMDCGhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.