Summary Of Safety and Clinical Performance (SSCP) for Healthcare Professionals and Patients

What is SSCP?

The manufacturer of implantable devices and class III devices—aside from custom-made or investigational devices—must prepare a summary of safety and clinical performance (SSCP) in accordance with Regulation (EU) 2017/745 on medical devices. A notified body (NB) must approve the SSCP before it is made public via EUDAMED. The manufacturer’s usage instructions must include all pertinent information to access this SSCP.

The clinical performance, safety, and clinical data of these high-risk devices must be disclosed in the SSCPs, according to Article 32 of EU MDR 2017/745. The intended end users of the devices—either medical professionals or patients, if applicable—must be able to access the document.

Objective of SSCP

Transparency and public access to the safety and clinical efficacy of medical devices are the primary goals of the SSCP.

The purpose of the SSCP is not to:

• Update the required details on implant cards or any compulsory documents.
• Provide general advice on the diagnosis or treatment of specific medical conditions; or
• Take the place of the instructions for use (IFU), which is the primary document that will be provided to ensure the safe use of a particular device.

What Resources Should Be Used for SSCP Preparation?

The details within the summary of safety and clinical performance (SSCP) should solely originate from the technical documentation of the device. Examples of such documentation encompass design verification/validation reports, risk management file, clinical evaluation reports, as well as plans and reports for post-market surveillance (PMS) and post-market clinical follow-up (PMCF). The device’s IFU can also be consulted for information if necessary when getting ready to submit the SSCP.

Summary of safety and clinical performance (SSCP) intended for healthcare professionals/users

The SSCP consists of two sections: one tailored for healthcare professionals or intended users, and, when applicable, a second section aimed at patients. It’s important to maintain consistent usage of medical terminology appropriate for both the medical device and the clinical context throughout the portion of the SSCP intended for healthcare professionals.

The following sections are incorporated in the portion of the SSCP designated for users/healthcare professionals:

• Device identification and general information
• Intended use of the device
• Device Description
• Risks and Warnings
• Summary of clinical evaluation and post-market clinical follow-up (PMCF)
• Possible diagnostic or therapeutic alternatives
• Suggested profile and training for users
• Reference to any harmonized standards and CS applied
• Revision History

To maintain clarity and accessibility, it’s advised to separate the information intended for patients/laypersons and for intended users/healthcare professionals into two distinct sections within the SSCP, with a “page break.”

Summary of safety and clinical performance (SSCP) for Patient

When the SSCP pertains to a device where providing information to patients is relevant, it should be written in layman’s terms. This means that medical terminology should be explained using simple language for better understanding.

As per the MDR, patients are considered intended recipients of the information in the SSCP, “if relevant.” Devices for which a part of the SSCP specifically intended for patients should be provided include:

• Implantable devices that require implant cards for patients and
• Class III devices intended for direct patient use
• Medical devices listed in MDR Annex XVI and qualifying for a summary of safety and clinical performance (SSCP), must be considered pertinent for patient information.

Following are the sections that are included in the Patients SSCP Part:

• Device identification and general information
• Intended use of the device
• Device Description
• Risks and Warnings
• Summary of clinical evaluation and post-market clinical follow-up (PMCF)
• Possible diagnostic or therapeutic alternatives
• Suggested training for users
• Document revision and date issued

What are the Language Requirements for SSCP?

SSCP documents should be available in languages accepted in the Member States where the device is intended to be sold, accompanied by an English version. Additionally, each SSCP document should specify the language in which it was validated by the Notified Body (NB).

What is the frequency of updating the SSCP?

According to Article 61 of Regulation (EU) 2017/745, the summary of safety and clinical performance (SSCP) must be updated at least once annually.

References