Summary of Safety and Clinical Performance (SSCP) is a new Regulatory requirement applicable for high-risk implantable and class III devices manufacturers. SSCP for these high-risk devices is imposed by the Article 32 of EU MDR 2017/745 and should include information about safety, clinical data and clinical performance of device. The document shall be accessible to the intended end users of the devices, either the healthcare professionals and/or patients. The SSCP, after validation by a notified body, is made available to public access through European Database on Medical Devices (EUDAMED).
What Is the Objective And Purpose Of SSCP?
SSCP document is expected to bring in more transparency and public access to safety and clinical information of a medical device.
SSCP is not intended for:
- Giving general advice on the diagnosis and treatment of specific medical conditions
- Replacing IFU as the main document for ensuring safe use of a device
- Replacing information on implant cards or in any mandatory documents
What are the Different Sections of SSCP?
SSCP document contains different sections such as:
- Identification of device and manufacturer
- Intended purpose of device
- Device description
- Description of undesirable effects, risks, warnings and precautions
- Summary of clinical evaluation and post- market clinical follow-up
- Probable diagnostic and therapeutic alternatives
- User profiles and specific trainings
- List of applied common specifications, standards and monographs
- Revision history
What are the Language Requirements for SSCP?
SSCP document should be provided in languages accepted in the Member States, where the device is to be sold along with an English version of the document.
What Resources Should Be Used for SSCP Preparation?
The information presented in the SSCP document should be entirely based on technical documentation of the device including, design validation report, risk management report, clinical evaluation report, as well as PMS and PMCF plan reports. If needed, the IFU (Instructions for Use) of device can also be used as a source of information for preparing the SSCP.
What Is the Update Frequency for SSCP?
SSCP shall be reviewed and updated (if needed) along with annual updates of Post- Market Clinical Follow-up (PMCF) and Periodic Safety Update Report (PSUR).
When Will the SSCP Become Publicly Accessible?
With the launch of the EUDAMED Database in May 2022, the SSCP is expected to be accessed publicly.
Are you looking for assistance in generating SSCP document for your product? Reach out to Freyr at sales@freyrsolutions.com.