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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Summary of Safety and Performance (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)SSP # Summary of Safety and Performance (IVDR) Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 29 of the [IVDR](/terms/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](/terms/notified-body), and is made available to the public through [EUDAMED](/terms/eudamed). ## What this means in practice The SSP is the [IVDR](/terms/ivdr) counterpart of the [MDR](/terms/mdr-reporting) [SSCP](/terms/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 theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Regulatory Summary of Safety and Clinical Performance(SSCP) Public-facing summary required for high-risk and implantable devices under EU MDR. ](/terms/sscp) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 IMDRF· 1 1. [1 Regulation (EU) 2017/746, Article 29 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 MDCG 2022-9 SSP Guidance Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/document/download/f4b7dfae-4d75-4c9d-b3fd-9e7a83fe2a52_en) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym SSP Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-summary-safety-performance) Learn in 60 seconds Card Lesson Quiz Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED. - · 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. - · 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. Remember this Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Regulatory and shared keywords. - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [MDR Article 117 ](/terms/mdr-article-117) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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