---
title: "Which devices need an SSCP under the EU MDR and what should it include?"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/sscp"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/sscp"
author: "Sorena AI"
description: "EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary."
published_at: "2026-05-09"
updated_at: "2026-05-26"
keywords:
  - "EU MDR SSCP"
  - "summary of safety and clinical performance"
  - "Article 32"
  - "EUDAMED"
  - "clinical evaluation"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "SSCP"
  - "EU MDR FAQ"
---
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# Which devices need an SSCP under the EU MDR and what should it include?

EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary.

*FAQ* *EU*

## EU MDR FAQ SSCP

Under EU MDR Article 32, an SSCP is required for implantable devices and class III devices, except custom-made or investigational devices.

Use this FAQ to check the SSCP trigger, prepare the right clinical and safety content, and keep the manufacturer, notified body, and EUDAMED steps clear.

An SSCP is required under EU MDR Article 32 for implantable devices and class III devices, other than custom-made or investigational devices. The manufacturer draws it up, the notified body validates the draft as part of conformity assessment, and after validation the notified body uploads it to EUDAMED. The document is public-facing: it should summarize safety, clinical performance, clinical evaluation, relevant PMCF information, alternatives, residual risks, warnings, and device/manufacturer identifiers in language clear to intended users and, where relevant, patients.

## Which devices need an SSCP?

The EU MDR trigger is specific: implantable devices and class III devices need an SSCP unless they are custom-made or investigational devices. Do not create the answer from a broad risk label alone; confirm classification, implantable status, intended purpose, and whether an exclusion applies.

The SSCP is not a marketing brochure, instructions for use replacement, implant-card replacement, or general treatment guide. Its purpose is public access to an updated summary of clinical data and other safety and clinical performance information for the device.

- Manufacturer role: draw up the SSCP, source it from technical documentation, keep it updated, manage translations, and verify the needed EUDAMED uploads before placing the device on the relevant market.
- Notified body role: validate the draft against required content and current technical documentation, upload validated SSCPs to EUDAMED, and consider PMS, PSUR, PMCF plan, PMCF evaluation report, and other relevant information during surveillance.
- EUDAMED role: make the SSCP publicly available and link it to the Basic UDI-DI; the public availability caveat is that some implantable class IIa and some class IIb implantable SSCP revisions may be uploaded before notified-body validation, so the revision history should state validation status.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Article 32 is the binding source for the SSCP trigger, manufacturer duty, notified-body validation, EUDAMED upload, public availability, and label or IFU reference.
- [MDCG 2019-9 Rev.1 - Summary of safety and clinical performance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4%5Fen?filename=md%5Fmdcg%5F2019%5F9%5Fsscp%5Fen.pdf&ref=sorena.io) - MDCG guidance for SSCP presentation, content, validation, translations, revision history, and EUDAMED upload mechanics.
- [EUDAMED - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED source for the database role in transparency and device lifecycle information.

## What evidence should support the SSCP?

The SSCP should be sourced from the device technical documentation. Keep a traceable pack showing where each public statement came from and how it remains aligned with the current technical file.

For the clinical evaluation link, retain the clinical evaluation plan and report, the clinical evidence used to support conformity, both favourable and unfavourable clinical data considered, and the PMCF plan and PMCF evaluation report where PMCF updates the clinical evaluation. Where equivalence is used, keep the equivalence rationale and the evidence access basis.

- Keep classification and implantable-status rationale, intended purpose, label and IFU references, Basic UDI-DI, manufacturer SRN, notified-body name and identification number, and the SSCP reference number.
- Keep the risk management file, design verification and validation reports, clinical evaluation report, PMS plan, PMCF plan and reports, PSUR inputs, vigilance or trend evidence, and IFU cross-references used in the SSCP.
- Keep revision history showing issue dates, change descriptions, validation language, notified-body validation status, translations sent to the notified body, and EUDAMED upload checks.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Annex XIV grounds the clinical evaluation and PMCF evidence that supports the SSCP's clinical performance and safety summary.
- [MDCG 2019-9 Rev.1 - Summary of safety and clinical performance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4%5Fen?filename=md%5Fmdcg%5F2019%5F9%5Fsscp%5Fen.pdf&ref=sorena.io) - MDCG guidance identifies technical-documentation sources for SSCP content, including risk management, clinical evaluation, PMS, PMCF, IFU, and revision records.
- [EUDAMED - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED source for the public database context and the system modules relevant to device, certificate, clinical, vigilance, PMS, and market-surveillance information.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Binding MDR source for Article 32 SSCP scope, validation, EUDAMED availability, and Annex XIV clinical evaluation and PMCF evidence.
  - Quote: "shall be made available to the public"
- [MDCG 2019-9 Rev.1 - Summary of safety and clinical performance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4%5Fen?filename=md%5Fmdcg%5F2019%5F9%5Fsscp%5Fen.pdf&ref=sorena.io) - SSCP-specific MDCG guidance for required sections, public-facing purpose, validation, upload, updates, translations, and evidence sources.
  - Quote: "presentation, content and validation"
- [EUDAMED - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED source for the database's transparency role and lifecycle/device information context.
  - Quote: "lifecycle of medical devices"

## Topic Guides

- [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain.
- [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records.
- [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact.
- [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): source-linked EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch.
- [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step.
- [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change.
- [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence.
- [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact.
- [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support.
- [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A source-linked EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff.
- [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): source-linked EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review.
- [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls.
- [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): source-linked EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs.
- [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Grounded EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews.
- [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact.
- [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance.
- [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition.
- [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): source-linked EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records.
- [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence.
- [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): source-linked EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence.
- [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records.
- [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): source-linked EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling.
- [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A source-linked EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records.
- [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence.
- [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records.
- [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment.
- [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment.
- [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records.
- [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records.
- [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts.
- [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance.
- [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records.
- [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md): EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence.
- [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap.
- [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products.
- [MDR vs IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
- [MDR vs Product Liability Directive evidence comparison](/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive.md): Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome.
- [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover.
- [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence.
- [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md): EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence.
- [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep.
- [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain.
- [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep.
- [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED.
- [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.

*Recommended next step*

*Placement: after implementation section*

## Use this EU MDR guide as a cited evidence workflow

Turn this EU Medical Device Regulation page into a repeatable workflow for product, legal, quality, procurement, support, and engineering teams. Keep citations, owners, evidence, and review triggers together.

- [Open Research Copilot](/solutions/research-copilot.md): Answer EU MDR scope, timing, and interpretation questions with cited outputs.
- [Talk through implementation](/contact.md): Review your scope, evidence model, controls, and next actions.


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