Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance (SSCP) is one of the new dimensions of the updated European Medical Device Regulations, EU MDR 2017/745. As specified in Article 32, the medical device manufacturers of Class III & All classes of implantable devices need to publish the SSCP in the Eudamed which is soon to be made public. With this new concept, the European Commission has taken a special care to provide critical, device safety related information to the intended users of the high-risk and implantable medical devices and healthcare professionals in a public domain.

Another notable point is that the SSCP shall be validated before uploading to Eudamed by the Notified Body on the contents of the document (initially prepared by the manufacturer), by confirming that the contents of the SSCP are most relevant to the Technical Documentation and does not incorporate the elements of a promotional nature. The readability of the SSCP shall also be retained by having the specific information directed to both healthcare professionals and patients. The presentation of the SSCP shall be clear and the medical terminology shall be consistent keeping the end users in mind. This would enhance the transparency in the flow of critical information to the end user. However, the validation by Notified Body is confined to only one language version.

All the stakeholders involved shall take proper care that the SSCP maintains its significance by not providing advice on the diagnosis or treatment of a particular medical condition. Further, in any case, the SSCP shall not replace the key regulatory documents like Implant Cards and IFU provided along with the devices. Specially, IFU shall be drafted keeping the provisions for SSCP like its URL to access SSCP in Eudamed database and Basic UDI-DI information linked with the device of interest.

The Technical Documentation will be the sole repertory of the SSCP. Particularly, documents like Design V&V reports, Risk management, CER, PMS documentation including PMCF are the key sources of SSCP. As in the case of IFU, the SSCP shall be translated into other EU languages where the medical device is expected to be made available. There should be one SSCP document for each EU language.

The SSCP is updated in Eudamed with the latest information available. When the PMCF evaluation report and the periodic safety update report (PSUR) are updated at least annually, the SSCP is reviewed and updated only when there is a need to ensure that any safety/clinical information in the SSCP remains correct and complete. If the SSCP has been updated with new information, the manufacturer shall submit the updated SSCP to the Notified Body during the submission of the required PSUR. If the SSCP has already been validated, the NB should re-validate the updated SSCP against the submitted and evaluated PSUR.

The Notified Body uploads a SSCP whenever it has been validated against relevant documents as part of Technical Documentation, and in the process replaces the uploaded SSCP at the initial certification with the currently validated revision. The SSCP document shall include a revision history and its purpose is to include SSCP revision number, issued date for the revision, description of the significant changes.