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    Summary of safety and clinical performance (SSCP)

    The summary of safety and clinical performance (SSCP) shall be laid out with an objective of it being easy for the intended user to interpret and, if relevant, to the patient. It shall be made available to the public via Eudamed. Along with all the other technical documents, the draft of the summary of safety and clinical performance shall also be submitted to the notified body involved in the conformity assessment and shall be validated by that body. After its authentication, the notified body shall upload the summary to Eudamed. The manufacturer shall mention all the information relevant to access this summary on the label or instructions for use.

    The objective of summary of safety and clinical performance (SSCP) is not to:

    • provide advice on the diagnosis or treatment of particular medical conditions, nor
    • replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular medical device, nor
    • replace the obligatory information on implant cards or in any other mandatory documents.
    SSCP

    To which devices summary of safety and clinical performance (SSCP) will be applicable and when to update?

    • The manufacturer shall draw up a summary of safety and clinical performance for implantable devices and for class III devices, other than custom-made or investigational devices.
    • For class III devices and class IIb implantable devices, other than sutures and staples etc., submit a draft summary of safety and clinical performance (SSCP) which has been updated within 12 months, regardless of whether there are new data or conclusions.
    • For class IIa implantable and IIb implantable devices, such as sutures, confirm that the SSCP in EUDAMED is in alignment with the current version of the Technical Documentation (TD), or provide an updated SSCP where required.
    • Update of the summary of safety and clinical performance (SSCP) at least annually as indicated

    Requirements as per Regulation (EU) 2017/745

    The summary of safety and clinical performance (SSCP) shall include at least the following aspects:

    • The identification of the medical device and the manufacturer, including the Basic UDI-DI and, if already issued, the Single Registration Number (SRN)
    • The intended purpose of the device and any indications, contraindications and target populations
    • A description of the medical device, including a reference to previous generation(s) or variants and a description of the differences, as well as, where applicable, a description of any accessories, other devices and products, which are intended to be used in combination with the medical device
    • Possible diagnostic or therapeutic alternatives
    • Reference to any harmonized standards and Common Standards (CS) applied
    • The summary of clinical evaluation as referred to in Annex XIV in Regulation (EU) 2017/745, and relevant information on post-market clinical follow-up
    • Suggested profile and training for users
    • Information on any residual risks and any undesirable effects, warnings and precautions

    FAQ:

    For implantable devices and class III devices, other than custom-made or investigational
    devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP)

    SSCP should update annually as indicated in Regulation (EU) 2017/746

    Yes. It is available on EUDAMED and on IFU/label, the manufacturer will mention the
    details where SSCP is available

    An SSCP (Summary of Safety and Clinical Performance) is a document required under Regulation (EU) 2017/745 for Class III and implantable medical devices. It provides a clear and accessible summary of a device’s safety and clinical performance, primarily intended for healthcare professionals and, where relevant, patients. The SSCP is reviewed and validated by a Notified Body, uploaded to the EUDAMED database, and must be referenced in the device’s label or instructions for use. It does not replace the Instructions for Use (IFU) or other mandatory documentation but provides transparency and informs users about the device’s safety, clinical data, and potential risks.

    Safety and clinical effectiveness are crucial because they ensure that a medical device performs as intended without causing harm to patients or users. This protects patients’ health and well-being by minimizing risks, undesirable effects, and complications. Clinical effectiveness confirms that the device provides the expected medical benefits, improving diagnosis, treatment, or health outcomes. Together, they build trust in the device’s reliability and support informed decisions by healthcare professionals and patients.

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

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

    2. The intended purpose of the device, including indications, contraindications, and target populations.

    3. A description of the medical device, including references to previous generations or variants, differences between them, and details of any accessories or products intended for combined use.

    4. Possible diagnostic or therapeutic alternatives to the device.

    5. References to any harmonised standards and Common Specifications.

    6. A summary of the clinical evaluation and post-market clinical follow-up information.

    7. Suggested user profile and training requirements.

    8. Information about any residual risks, undesirable effects, warnings, and precautions.

    The Summary of Safety and Clinical Performance (SSCP) is reviewed and approved by the notified body involved in the conformity assessment of the medical device. The manufacturer submits the draft SSCP to this notified body, which validates and authenticates it. After approval, the notified body uploads the finalized SSCP to Eudamed for public access.

    Maven offers expert guidance and comprehensive support in preparing the Summary of Safety and Clinical Performance (SSCP) for implantable and Class III medical devices, ensuring compliance with Regulation (EU) 2017/745. Our team assists manufacturers in drafting, reviewing, and updating SSCP documents accurately and clearly, making them easy for intended users and patients to understand. We also support the validation process with notified bodies and help manage timely updates aligned with technical documentation. With Maven Profserv, you can be confident that your SSCP meets all regulatory requirements and is ready for submission and publication on Eudamed.

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