--- title: "SSCP Definition & Meaning | MedTech Terms" description: "Public-facing summary required for high-risk and implantable devices under EU MDR. Plain-English Regulatory definition for MedTech teams, with examples and rela" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sscp#term", "name": "Summary of Safety and Clinical Performance", "alternateName": "SSCP", "description": "Per MDR Article 32, manufacturers must produce an SSCP for implantable and Class III devices. 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This includes providing the SSCP to the Notified Body for validation." } }, { "@type": "Question", "name": "How often must the SSCP be updated?", "acceptedAnswer": { "@type": "Answer", "text": "The SSCP must be updated whenever necessary, and at least annually for implantable devices and Class III devices, to reflect new safety or clinical data as specified in EU MDR Article 32." } }, { "@type": "Question", "name": "What is the primary purpose of the SSCP?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose of the SSCP is to provide transparent, publicly accessible information about the safety and clinical performance of implantable and Class III medical devices, enabling patients and healthcare professionals to make informed decisions." } }, { "@type": "Question", "name": "Who validates the SSCP before publication?", "acceptedAnswer": { "@type": "Answer", "text": "The Notified Body involved in the device's conformity assessment is responsible for validating the SSCP, ensuring its accuracy and completeness before it is published on EUDAMED." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Summary of Safety and Clinical Performance [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)SSCP # Summary of Safety and Clinical Performance Public-facing summary required for high-risk and implantable devices under EU MDR. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per [MDR](/terms/mdr-reporting) Article 32, manufacturers must produce an SSCP for implantable and Class III devices. The validated document is published on [EUDAMED](/terms/eudamed) so patients and healthcare professionals can access key clinical evidence. What the regulation says The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745), specifically Article 32 and Annexes III and XIV, mandates the Summary of Safety and Clinical Performance (SSCP). This document provides public access to key safety and clinical data for implantable devices and Class III devices. It must be validated by a [Notified Body](/terms/notified-body) as part of the conformity assessment process, as outlined in EU MDR Annex VII, Section 4.10, and subsequently made available on the European database on medical devices ( [EUDAMED](/terms/eudamed)). ## What this means in practice SSCPs are validated by the [Notified Body](/terms/notified-body) and updated at least annually for implants and Class III. They must be written in plain language for the patient sections. ## Examples - A manufacturer of a Class III cardiac stent drafts an SSCP detailing its clinical benefits, risks, and performance data, which is then submitted to their Notified Body for validation. - Following a post-market clinical follow-up study, a manufacturer updates the SSCP for their implantable hip prosthesis to reflect new long-term performance data and any updated risk information. - A healthcare professional reviews the SSCP on EUDAMED for a new spinal implant to understand its clinical evidence and compare it with other available devices. Common pitfalls - • manufacturers may underestimate the importance of plain language requirements for the patient-facing sections, leading to documents that are not easily understood by the target audience. - • Insufficient detail in the clinical performance sections can lead to Notified Body queries and delays in validation. - • Failing to establish a robust process for annual updates and re-validation, especially for devices with ongoing clinical data collection, is a common pitfall. - • Not aligning the SSCP content precisely with the Clinical Evaluation Report (CER) and other technical documentation can result in inconsistencies and regulatory scrutiny. - • Overlooking the need for translation into relevant EU languages for the patient and healthcare professional sections can impede timely publication. ## Frequently asked questions Who is responsible for preparing and updating the SSCP? The device manufacturer is responsible for drafting, updating, and ensuring the accuracy of the SSCP. This includes providing the SSCP to the [Notified Body](/terms/notified-body) for validation. How often must the SSCP be updated? What is the primary purpose of the SSCP? Who validates the SSCP before publication? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer) ### 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 (5) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Quality System](/ecosystems/quality-system) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MDCG· 1 European Commission· 1 IMDRF· 1 1. [1 MDCG 2019-9 SSCP Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_9_sscp_en_0.pdf) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_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 SSCP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sscp) Learn in 60 seconds Card Lesson Quiz Public-facing summary required for high-risk and implantable devices under EU MDR. - · SSCPs are validated by the Notified Body and updated at least annually for implants and Class III. - · They must be written in plain language for the patient sections. - · The validated document is published on EUDAMED so patients and healthcare professionals can access key clinical evidence. Remember this Watch out: manufacturers may underestimate the importance of plain language requirements for the patient-facing sections, leading to documents that are not easily understood by the target audience. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EUDAMED ](/terms/eudamed) - [Clinical Evaluation Report(CER) ](/terms/cer) You may also need Auto-suggested from Regulatory and shared keywords. - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) [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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