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, 2022, the SSCP can be accessed by anyone and everyone.
The SSCP should always have 2 parts. One part for healthcare professionals, and a second part for patients. Ensuring the SSCP includes a writeup that targets both audiences requires medical writers with strong technical writing skills and writers that transform complex scientific information into easy to read content.
The SSCP has 9 sections that need to be addressed:
1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN (single registration number)
2. The intended purpose of the device and any indications, contraindication and target populations
3. A description of the device, including a reference to previous generations(s) of variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device.
4. Information on any residual risks and any undesirable effects, warnings and precautions
5. The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up
6. Possible diagnostic or therapeutic alternatives
7. Suggested profile and training for users
8. Reference to any harmonized standards and CS applied
9. Revision history
While the SSCP provides a plethora of information, MDCG 2019-9 clearly states that SSCP is not intended to:
Unlike the Post-Market Clinical Follow-Up (PMCF) plans and report, the SSCP is only required for implantable and class III medical devices. Custom made and investigational devices are the exceptions that do not require an SSCP.
The data needs to be presented in an objective manner that clearly summarizes both favorable data and unfavorable data. Putting together an SSCP that includes the devices benefit to risk, diagnostic and therapeutic alternatives as well as the specific conditions in which the device is considered can be a real challenge. All SSCPs need to be entered into the Eudamed. The fact that SSCPCs will be available to the public as soon as Eudamed is updated and goes live in 2022 puts even more pressure on getting the SSCP right.
Criterion Edge works with experienced medical writers to help ensure that the critical SSCP elements, such as the source of quality data, are correctly disclosed in the SSCP. Chat with us about our experience with SSCPs.
We had a large turnout at our webinar on April 29, 2020, “How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review.” We ended with many unanswered questions. To answer these and more questions, President Laurie Mitchell is coming back to host a Question & Answer session LIVE.
Jun 4, 2020 11:00 AM in Pacific Time (US and Canada)