FAQEU

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.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 26, 2026
Questions
2

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 26, 2026
Overview

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.

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2 of 2 questions
Question 1

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.
Citations
Question 2

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.
Citations
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Primary sources

References and citations

EUDAMED - European Database on Medical Devices
webgate.ec.europa.eu
Referenced sections
  • Commission EUDAMED source for the public database context and the system modules relevant to device, certificate, clinical, vigilance, PMS, and market-surveillance information.
"better access to information"
MDCG 2019-9 Rev.1 - Summary of safety and clinical performance
health.ec.europa.eu
Referenced sections
  • MDCG guidance identifies technical-documentation sources for SSCP content, including risk management, clinical evaluation, PMS, PMCF, IFU, and revision records.
"sourced entirely from the technical documentation"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Annex XIV grounds the clinical evaluation and PMCF evidence that supports the SSCP's clinical performance and safety summary.
"Both favourable and unfavourable data"
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