Summary of Safety and Clinical Performance (SSCP) is a public-facing document required under EU MDR 2017/745 Article 32 for implantable and Class III devices, excluding custom-made and investigational products. It summarizes a device’s clinical evidence and safety profile for healthcare professionals and, where relevant, patients, and is published in EUDAMED after Notified Body validation.
What is the Summary of Safety and Clinical Performance (SSCP)?
The Summary of Safety and Clinical Performance (SSCP) is one of the transparency instruments introduced by the EU Medical Device Regulation (MDR) 2017/745. It gives the public a plain summary of the clinical data and safety information that supports a device’s CE marking, drawn from the manufacturer’s technical documentation and clinical evaluation.
The SSCP sits at the end of the clinical evaluation chain. The Clinical Evaluation Report (CER) holds the confidential, detailed analysis, and the SSCP distills that analysis into a document that intended users can actually read. Article 32 requires it for implantable devices and Class III devices, other than custom-made or investigational ones. Notified Body validation and publication in EUDAMED make it a controlled public record rather than a marketing asset.
Why Summary of Safety and Clinical Performance (SSCP) matters in medical device development
An SSCP is a certification deliverable, not an optional add-on. The Notified Body validates the draft as part of the conformity assessment under Article 52, so a weak or inconsistent SSCP can hold up a CE certificate. Indications that appear in the SSCP but are not backed by clinical evidence in the CER are treated as non-conformities.
The document is also permanent and public. Once the Notified Body uploads it to EUDAMED, patients, clinicians, competitors, and regulators can all read it. A claim that overstates performance, or a contradiction between the SSCP and the instructions for use, becomes a visible liability. Because the SSCP must track post-market data, it ties directly to PMS, PMCF, and PSUR cycles. Outdated safety information is a compliance gap, not just a housekeeping problem.
How the Summary of Safety and Clinical Performance (SSCP) process works
MDCG 2019-9 Rev 1 is the guidance that Notified Bodies apply. It fixes the section structure and, for many devices, defines two distinct audiences. The core steps:
- Confirm the device needs an SSCP: implantable or Class III, excluding custom-made and investigational products.
- Extract source content from the technical documentation, the CER, the risk management file (ISO 14971), and the PMS plan.
- Draft the healthcare professional section in clinical and technical language: device description, intended purpose, indications, contraindications, clinical performance with endpoints, and residual risks.
- Draft the layperson section where required, in plain language with no unexplained jargon, for implantable devices with patient implant cards and Class III devices used directly by patients.
- Present both favorable and unfavorable data objectively, with risks quantified.
- Translate into the languages of the member states where the device is sold, with an English version included.
- Submit the draft to the Notified Body, which validates it and uploads the approved version to EUDAMED.
The manufacturer then records where the SSCP can be found on the label or in the instructions for use, and revises it on the same cadence as the PSUR.
Common challenges and best practices
The layperson section is where most SSCPs fail at review. Teams write a strong clinical section, then paste a shortened copy as the lay summary, which breaks the plain-language requirement. Write the patient section separately, and test its readability against a defined tool instead of assuming it reads clearly.
Consistency is the second recurring problem. The intended purpose, indications, and contraindications in the SSCP must match the IFU, the labeling, and the scope of the CER. A population stated more broadly than the clinical evidence supports, for example, “all patients” when the data covers adults only, generates an immediate query.
Good practice treats the SSCP as a living document. Assign an owner, link it to the risk file and PMS outputs, and revise it whenever the benefit-risk conclusion changes. Keep the tone neutral, since promotional wording lowers both regulatory acceptance and, for AI-driven search, citation value.
How SJML helps with the Summary of Safety and Clinical Performance (SSCP)
SJML supports Summary of Safety and Clinical Performance (SSCP) work as part of its Compliance-as-a-Service offering. Its QARA and clinical teams handle clinical evaluation deliverables, including CEP, CER, literature review, and SSCP preparation, drawing content from the technical documentation and risk management file. The same teams manage post-market surveillance planning across PMS, PMCF, and PSUR, along with EU MDR/IVDR registration, so the SSCP stays aligned with the evidence and the wider technical file. Support spans Class I through Class III devices, from startups to established OEMs, with regulatory strategy and Notified Body engagement handled alongside the writing.
Frequently asked questions
An SSCP is required for implantable devices and Class III devices under EU MDR 2017/745 Article 32, excluding custom-made and investigational devices. It does not apply to Class I, Class IIa, or non-implantable Class IIb devices. For legacy devices moving from the MDD to the MDR, the SSCP is prepared at the first MDR certification or renewal.
The Clinical Evaluation Report (CER) is a confidential, detailed technical document submitted to the Notified Body and regulators. The Summary of Safety and Clinical Performance (SSCP) is the public summary drawn from it, written for intended users and, where relevant, patients. The CER holds the full analysis, while the SSCP presents the conclusions in an accessible form and is published in EUDAMED.
The Notified Body involved in the conformity assessment validates the draft SSCP under Article 52. After validation, the Notified Body uploads the approved SSCP to EUDAMED, the EU database for medical devices, where it is publicly accessible. The manufacturer must state on the label or in the instructions for use where the SSCP can be found.
An SSCP is updated whenever post-market surveillance, PMCF, risk management, or clinical evaluation produces information that makes the existing summary outdated. In practice, it is revised on the same cadence as the Periodic Safety Update Report (PSUR) and at each certificate renewal, so the public summary keeps reflecting the current benefit-risk profile of the device.
Related terms
- Clinical Evaluation Report (CER)
- Clinical Evaluation Plan (CEP)
- Post-Market Clinical Follow-up (PMCF)
- Periodic Safety Update Report (PSUR)
- EU MDR 2017/745
