How often must the SSCP be updated?

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.

What is the primary purpose of the SSCP?

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.

Who validates the SSCP before publication?

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.

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RegulatoryRegulated Pathways Quality System Clinical Evidence Global Markets Startup LifecycleSSCP

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 CyberLast reviewed May 5, 2026

Definition

Per MDR Article 32, manufacturers must produce an SSCP for implantable and Class III devices. The validated document is published on EUDAMED so patients and healthcare professionals can access key clinical evidence.

What the regulation says

The EU MDR (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 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).

What this means in practice

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.

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

The device manufacturer is responsible for drafting, updating, and ensuring the accuracy of the SSCP. This includes providing the SSCP to the Notified Body for validation.

Cross-references

Part of

A larger framework or document this term belongs to.

EU Medical Device Regulation(MDR)

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.

Regulatory

EUDAMED

European Database on Medical Devices.

Clinical & Trials

Clinical Evaluation Report(CER)

Documented assessment of clinical data demonstrating EU MDR conformity for a device.

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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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.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

Primary references

3 sources

Link health: 3 verified· last checked 2026-06-20

MDCG·1European Commission·1IMDRF·1

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On this term

Category: Regulatory
Acronym: SSCP
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

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.

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