The Summary of Safety and Clinical Performance {SSCP} is a document that describes the safety of a medical device. According to the Medical Device Regulations, the document is an obligation that manufacturers of certain high-risk medical devices need to fulfil before they apply for CE certification to market their device in the European Union. The document must be verified by a notified body and made publicly available.
The SSCP is required for implantable devices and class III devices, except for custom-made or investigational devices. Implantable devices are devices that are completely introduced inside the human body and are intended to be kept in place after the procedure for at least 30 days. Class III devices are high-risk devices and require monitoring during their lifetime.
The document consists of two main sections. The first section is meant for healthcare professionals and is highly technical. The second part, which is the patient-information section, must be provided only for implantable devices supplied with implant cards for patients, or for class III devices intended to be directly used by patients. This section must be written in simple language. Though the information is provided to the patient, the patients is encouraged to consult a healthcare professional in case of a doubt.
The technical section has 9 points, while the patient-information section has 7 points. These include the following:
- Information on the identification of the device and its manufacturer including the class of the device, and the notified body that would validate the SSCP
- The intended use of the device along with the patients who can use it, and conditions in which it cannot be used
- A description of the device, including a description of accessories or devices that it should be used with. A reference to previous generations of the device, if present, should be mentioned, along with the differences between the generations
- Information regarding the possible risks and other safety aspects of the device, including any corrective action that has been taken to improve its safety
- A summary of the clinical evaluation that the device has undergone and its outcomes, as well as information about the follow-up following the marketing of the device
- Possible alternatives to the device, along with a comparison with the alternatives
- Suggested profile and training for users
- Reference to any harmonized standards and common specifications (CS) applied
- Any details of revision to the document
The source of the information for preparing the document should be technical documents related to the device which may include design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports.
The SSCP document should be in English, as well as in the local languages, according to the requirements of the Member States, where the device is likely to be sold. The document should be updated on a regular basis as required.
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This article is for informational purposes only and not intended to replace the relationship between the doctor and the patient. It should not be used for self-treatment by patients or by doctors to treat patients. Consult your doctor before using any of the above information.
Last updated on: 14-10-2020
Copyright: InsiWi Solutions LLP
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