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SSP

Summary of Safety and Performance

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    In the EU IVDR 2017/746, there is a requirement to document and submit a Summary of Safety and Performance (SSP) for class C and Class D IVD. This is a new requirement compared to IVDD. The aim of SSP is to enhance transparency and provide public access to the data of safety and performance of IVDs.

    In spite of this being a new requirement, Maven Profcon Services LLP has already prepared on SSP for their clients and developed best approach that you can follow for your submission.

    SSP is advantageous for both the patient and healthcare professional as it is available on the public database patients can use it to research about the device and learn more about it. Healthcare professionals can use to understand safety and performance of the device already in market. However, note that the SSP is not intended to replace the IFU.

    Summary-of-Safety-and-Performance

    The SSP shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of SSP is submitted to Notified Body involved in the conformity assessment and shall be validated by that body. After its validation the NB uploads the SSP to EUDAMED and the manufacturer shall mention on the label and IFU where the SSP will be available.

    The manufacturer is responsible for translation of the SSP to other official EU languages. If the SSP uploaded by NB is in language other than English then the manufacturer is responsible for translating it to English language is in a language other than English, then an English translation should be provided by the manufacturer and the NB will upload the English translation to EUDAMED.

    The SSP must include the following:

    • Identification of device i.e. Basic UDI-DI, and identification of manufacturer and single registration number
    • Intended purpose, indication, contraindications, target populations
    • Reference to harmonized standards and common specifications
    • Summary of performance evaluation and relevant information of PMPF
    • Description of the device and its accessories, including a reference to previous generations or variants
    • suggested profile and training for users
    • information on any residual risks and any undesirable effects, warnings and precautions

    FAQ:

    The Summary of Safety and Performance (SSP) is a new requirement under the EU In Vitro Diagnostic Regulation (IVDR 2017/746) for Class C and Class D in vitro diagnostic devices. It is a publicly available document designed to enhance transparency by providing clear, understandable information about the safety and performance of an IVD device. The SSP helps patients and healthcare professionals by allowing access to data on the device’s intended use, risks, performance, and details. It is submitted to and validated by a Notified Body, then published on the EUDAMED public database. The SSP complements, but does not replace, the Instructions for Use (IFU).

    Under the EU In Vitro Diagnostic Regulation (IVDR 2017/746), a Summary of Safety and Performance (SSP) is mandatory for all in vitro diagnostic devices classified as Class C and Class D. This is a new requirement compared to the previous IVDD regulation. The SSP must be prepared, submitted to the Notified Body for validation, and made publicly accessible via the EUDAMED database.

    The Summary of Safety and Performance (SSP) must include the following key information:

    1. Identification of the device, including the Basic UDI-DI, manufacturer details, and Single Registration Number (SRN)

    2. Intended purpose, indications, contraindications, and target population

    3. References to applicable harmonized standards and common specifications

    4. Summary of performance evaluation and relevant Post-Market Performance Follow-up (PMPF) information

    5. Description of the device and its accessories, including references to previous generations or variants

    6. Suggested user profile and training requirements

    7. Information on any residual risks, undesirable effects, warnings, and precautions

    The SSP (Summary of Safety and Performance) is required under EU IVDR 2017/746 for Class C and D IVDs. It provides a publicly accessible summary of the device’s safety and performance, ensuring transparency for patients and healthcare professionals via EUDAMED. In contrast, the SSCP (Summary of Safety and Clinical Performance) is required under EU MDR 2017/745 for certain high-risk medical devices (non-IVDs). It includes a detailed summary of safety and clinical performance, helping users understand the benefits and risks. While both aim to enhance transparency, SSP is for IVDs, and SSCP is for non-IVD medical devices.

    Maven Profcon Services LLP specializes in preparing compliant SSPs for Class C and D IVDs under EU IVDR 2017/746. Our proven process ensures regulatory alignment and smooth submission to Notified Bodies and EUDAMED. We draft clear, user-friendly SSPs tailored for both healthcare professionals and patients, covering all mandatory elements like device details, intended use, performance data, risk info, and training guidance. We coordinate Notified Body reviews, manage multilingual translations, and advise on labeling and IFU updates referencing the SSP. Partnering with Maven ensures IVDR compliance, boosts transparency, and delivers accessible, accurate device information to regulators, professionals, and end-users.

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