Summary of Safety and Clinical Performance

What is SSCP?

The Summary of Safety and Clinical Performance (SSCP) is a requirement of the EU Medical Devices Regulation (EU MDR).

SSCP provides a summary of the risks and benefits of certain devices and must be provided for all Class III and implantable devices (other than custom-made or investigational devices) and will be available in EUDAMED. The IFU shall contain all that is needed to directly find the SSCP in EUDAMED.

This factsheet provides healthcare professionals (HCPs) with more information on SSCP.

Purpose of SSCP

The SSCP allows public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.

The SSCP will be an important source of information for intended users – both HCPs and, if relevant, for patients. It is one of several means intended to fulfill the objectives of EU MDR to ensure a robust, transparent, and sustainable regulatory framework and maintain a high level of safety.

SSCP Contents

The SSCP contains easily understood and relevant information for HCPs and, when relevant, the public. This information is presented in separate sections and uses language and terms appropriate for the respective audience.

Key information captured in the SSCP includes the description and intended use of the devices in scope, associated risks and warnings, an objective summary of existing and planned clinical data, and possible diagnostic or therapeutic alternatives.

The SSCP is updated continuously through the products life cycle as new clinical data or other relevant information is available.

Accessing the SSCP

After review and approval by a Notified Body, it is the Notified Body’s responsibility to upload the SSCP into EUDAMED.

At the latest  when EUDAMED becomes mandatory the SSCP can be obtained from the Device section of EUDAMED on ec.europa.eu/tools/eudamed.

Prior to the EUDAMED mandatory usage date, the manufacturer makes the SSCP available upon request.

What is EUDAMED?

EUDAMED is a secure web application used to capture and share data related to medical devices placed on the EU Market. The system is comprised of a restricted site with six interconnected modules where relevant stakeholders create content. The six modules relate to:

  1. Actor Registration
  2. Unique Device Identification (UDI) and Device Registration (incl. SSCP)
  3. Notified Bodies and Certificates
  4. Clinical Investigations and Performance Studies
  5. Vigilance
  6. Market Surveillance

A separate public facing website is also available to provide access to a large portion of the information and strengthen confidence in the safety of medical devices available on the market.

Set up by EU Commission, EUDAMED aims to enhance overall transparency through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.