May 19, 2020

The Summary of Safety and Clinical Performance (SSCP) is a Required Part of Medical Device Regulation (MDR) 2017/745: Is Your Organization Ready?

Blast off for succession

Author: Suzanne Broussard

The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and relevant patients access to current clinical data and other information about the safety and clinical performance of the medical device. 

SSCP is 1 of 2 yearly reports required of manufacturers to remain complaint under MDR to market medical devices in the European Union. The 2 reports are the Product Safety Update Report (PSUR) and the Summary of Safety and Clinical Performance (SSCP). The SSCP is not the same as the regular CER update. The SSCP needs to be updated when the PMCF and PSUR are updated as part of the ongoing lifecycle of these regulatory documents. 

The specific requirements of the SSCP can be found in Article 32 of MDR 2017/745. In addition, the European Union released MDCG 2019-9: Summary of safety and clinical performance, A guide for manufactures and notified bodies to provide guidance on the presentation of content in the validation of the SSCP.  

The guidance document outlines the minimum content required, and the manufacturer is encouraged to include additional information to enhance the readers understanding of the device’s safety and performance. Of course, the additional information cannot include promotional material and should not interfere with readability. Manufacturers should also keep in mind that the SSCP must be validated by notified bodies (NB); the guideline also provides information for NBs that the manufacturer can use to ensure that the SSPC includes all the relevant information. 

Another point to consider is that the target audience is healthcare workers as well as relevant patients. The European Commission considers relevant patients the target audience in special circumstances where the patient is directly engaged in the use of the device, such as implantable devices for which patients will be given an implant card and class III devices that are intended to be used directly by the patient.  

However, once the European Database on Medical Devices (Eudamed) database goes live May 26, 2022the SSCP can be accessed by anyone and everyone.  

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May 11, 2020

The Summary of Safety and Clinical Performance (SSCP) Provides Valuable Information to Health Care Providers, Patients, and Manufacturers

Author: Suzanne Broussard

Medical report checkoff

Is your organization ready to display to the world your medical devices safety and performance record? The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements imposed by manufacturers by the European Commission in Medical Device Regulations (MDR)2017/745 for implantable devices and class III devices. And, SSPC will go virtual when EUDAMED roles out in 2022. 

The SSCP is intended to provide intended users (healthcare professionals, and if relevant patients) with an updated summary of the device’s safety, clinical data, and clinical performance. This enhanced transparency provides everyone with adequate access to the devices clinical data, including your customers and your competitors.  

The SSCP should be sourced directly from the technical documentation, including the clinical evaluation report (CER), post-market surveillance, and post-market clinical follow-up (PMCF). And, the SSCP “shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (EUDAMED).” The SSCP must be updated at least annually. 

There are added benefits to making the SSCP public knowledge that can benefit manufacturers. Organizations can utilize the public information to their advantage. For example, manufacturers can use competitors SSCPs to:  

  • Justify their devices proposed pre-market and post-market studies 
  • Understand other devices strengths and weaknesses to improve your device 
  • Justify risk  
  • Increase market awareness 

Deadlines Extended to Allow Citizens Time to Safely Respond to the COVID-19 pandemic. 

The European Commission has proposed to extend the deadline for MDR compliance by one year (at this time waiting for approval by member states and publication in the Official Journal). The launch of EUDAMED has also been delayed. Now, EUDAMED will be launched together with the in-vitro medical devices in May 2022. 

The SSCP is still required to be part of MDR 2017/745 even though the launch of EUMADED has been moved back. 

A silver lining to the current health crises is that medical device manufacturers now have more time to become fully compliant with the European Commission regulations.  

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