Who validates the SSP before it is published?

The notified body involved in the device's conformity assessment must validate the Summary of Safety and Performance before it is made publicly available through EUDAMED. This validation step distinguishes the SSP from purely manufacturer-authored marketing content.

How is the IVDR SSP different from the MDR Summary of Safety and Clinical Performance?

The SSP is the IVDR counterpart of the MDR's SSCP, but it summarises performance evaluation evidence, analytical and clinical performance, rather than clinical investigation data specific to a therapeutic or implantable device. Both documents share the goal of giving patients, clinicians, and laboratories public access to key safety and performance information without requiring access to the full technical file.

Who is the intended reader of an SSP, and why does that matter for drafting it?

Article 29 requires the SSP to be written so it is clearly understood by the intended user and, where relevant, the patient, which means manufacturers must avoid dense technical jargon and structure the summary for a lay or semi-technical audience. A common drafting mistake is reusing language lifted directly from the performance evaluation report without adapting it for public readability.

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RegulatoryRegulated Pathways Global Markets Startup LifecycleSSP

Summary of Safety and Performance (IVDR)

Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

Article 29 of the IVDR requires manufacturers of Class C and D devices (except performance studies) to draw up a Summary of Safety and Performance. The SSP is written in a way clearly understood by the intended user and, where relevant, the patient, is validated by the notified body, and is made available to the public through EUDAMED. It covers the intended purpose, a summary of scientific validity and analytical and clinical performance, metrological traceability, residual risks, and the suggested profile and training of users.

What the regulation says

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, adopted on 5 April 2017 and generally applicable from 26 May 2022, establishes the Summary of Safety and Performance (SSP) requirement in Article 29. Manufacturers must prepare an SSP for Class C and D devices, excluding devices for performance studies. The document must be understandable to the intended user and, where relevant, the patient. The draft forms part of the documentation submitted to the notified body involved in conformity assessment, which validates the SSP and uploads it to EUDAMED for public access. Article 29 specifies minimum content, including device and manufacturer identification, intended purpose, indications, contraindications, target populations, and a device description. It also requires references to applicable harmonised standards and common specifications, a summary of the performance evaluation under Annex XIII, relevant post-market performance follow-up information, metrological traceability of assigned values, suggested user profiles and training, and residual risks, undesirable effects, warnings and precautions. The manufacturer must indicate on the label or instructions for use where the SSP is available. For MedTech stakeholders, the SSP is a regulated public summary, not a substitute for the underlying technical documentation or performance evaluation.

What this means in practice

The SSP is the IVDR counterpart of the MDR SSCP. It plays an important transparency role: hospitals, laboratories, and patients can review claimed performance and post-market findings for high-risk IVDs without accessing the technical file.

Examples

A laboratory technician reviews the SSP for a high-risk infectious disease diagnostic test to understand its analytical performance claims and user training recommendations.
A patient diagnosed with a complex genetic condition accesses the SSP for an associated companion diagnostic to learn about its intended purpose and residual risks.
A hospital procurement team compares the metrological traceability statements in the SSPs of different in vitro diagnostic devices before making a purchasing decision.

Common pitfalls

•Manufacturers often underestimate the effort required to make the SSP accessible to a lay audience, leading to documents that are too technical or use excessive jargon.
•Failing to adequately update the SSP throughout the device's lifecycle can lead to inconsistencies between the public document and the most current safety and performance data.
•Not obtaining proper notified body validation for the SSP before its publication can result in non-compliance and delays in market access or continued availability.

Frequently asked questions

Article 29 requires manufacturers of Class C and Class D devices to prepare a Summary of Safety and Performance, with the exception of devices intended solely for performance studies. Class A and Class B devices are not subject to this requirement.

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EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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EUDAMED

European Database on Medical Devices.

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Summary of Safety and Clinical Performance(SSCP)

Public-facing summary required for high-risk and implantable devices under EU MDR.

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Acronym: SSP
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Updated: 7/25/2026

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Publicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED.

·The SSP is the IVDR counterpart of the MDR SSCP.
·It plays an important transparency role: hospitals, laboratories, and patients can review claimed performance and post-market findings for high-risk IVDs without accessing the technical file.
·The SSP is written in a way clearly understood by the intended user and, where relevant, the patient, is validated by the notified body, and is made available to the public through EUDAMED.

Remember this

Watch out: Manufacturers often underestimate the effort required to make the SSP accessible to a lay audience, leading to documents that are too technical or use excessive jargon.

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