The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the manufacturer. Medical manufacturers will now have to submit a summary of safety and clinical performance (SSCP) for their products. This is part of the European Union’s regulatory framework on medical devices, which was updated in September 2019, and the first revision was published very recently in march 2022.
Revision 1 specifically constructs the “clarification on the association of the SSCP with the Basic UDI-DI in EUDAMED”.
Apart from this new report, they also have used a manufacturer reference number. These recent changes have been discussed for a while now, but manufacturers need more detailed information considering they require to submit these reports annually.
Origin of SSCPs
The Summary of Safety and Clinical Performance (SSCP) is a report on the product’s safety and efficacy and a summary of the clinical data that has been collected to demonstrate this. The information provided in this document is intended to be used by healthcare professionals when deciding whether or not a medical device should be used in their treatment of patients.
The SSCP report is also an essential tool for patients to choose between different options of treatment or surgical interventions. It helps them understand whether a product has been tested in clinical trials, how well it performed, the risks along with many other properties.
The concept of SSCP came from the need for the MDR to address real-world problems like device performance and public trust. In addition, several largely well-publicized medical device failure cases sped up the process. The point is that currently, the MDR is intended to limit potential issues by providing a transparent regulatory framework. SSCP is designed to meet the MDR objective of transparency and adequate access to information.
The objective is reinforced by requiring manufacturers to release SSCPs publicly. However, not all devices need these reports. Currently, SSCP is required only for class III and implantable devices. These new regulations give consumers, and healthcare professionals access to information that had previously been only accessible through manufacturers or notified bodies.
Basics of SSCPs
An SSCP document can provide information on the medical device, including general information about the device, a description of the clinical data of the device, and a description of possible therapy alternatives. The statistics are derived directly from technical documentation, including design validation reports, risk management reports, and the CER, PMS, and PMCF reports.
While the SSCP does provide relevant clinical data, it is not to be used as a guide or manual. The MDCG 2019 9 mentions that the purpose of SSCP is not intended to “provide general advice on the diagnosis or treatment of particular medical conditions or replace the instructions for use (IFU) or act as mandatory information on implant cards or in any other mandatory documents.”
The purpose of SSCP is purely to provide relevant essential information.
The MDR requires the manufacturers to assign an identifier or reference number to each SSCP that is unique to it. It doesn’t have to be an extremely complicated number, just a serial number that makes it identifiable among the SSCP of other devices from the same manufacturer.
MDR also requires the manufacturer to update the SSCP, which will be saved in the Eudamed. So, from now on, when the PMCF evaluation report and PSUR are updated annually, the SSCP will be updated as well to keep up with the technical documentation.
Additionally, all SSCPs should have a dedicated part for doctors/medical personnel. For obvious reasons, the section dedicated to doctors should reflect with appropriate depth of information and terminology.
MDR discourages the use of abbreviations and acronyms and encourages a simple, unambiguous format of text. Also, laypeople terms should be used in the patient’s section of the document with easy-to-read font size and type used in all sections.
What does an SSCP include?
The document must be completed by each manufacturer in the languages in which the device will be marketed and in English and should include:
1. A general description of the device and its intended use. It should also identify the device and the manufacturer.
2. The indications, and contraindications, along with the target demographic.
3. A description of the previous generations of this device, variations, and associated devices and accessories.
4. A description of any adverse events, residual risks, and warnings.
5. A clinical evaluation according to Annex XIV along with details of post-market clinical follow-up.
6. Appropriate information from clinical evaluation information and PMCF for patients.
7. Mention diagnostic and therapeutic alternatives
8. Suggested experience and training for users
9. List of all applied common specifications (CS) and international standards
10. Revision history
How to write one
Create and update templates
Misalignment among PMS risk management instruction and clinical evaluation could cause difficulties in implementing SSCPs. A clinical evaluation report template is particularly recommended the update the clinical information needed for the completion of the SSCP in CERs. It may also include a change of template when the notification body receives feedback, or a new guidance document is released. Our recommendation is to create templates to be used in the PSUR, SSCP, PMCF, and CER.
Use simple language
The SSCP is a regulatory document, and its intended audience is health professionals and patients; therefore, this should be structured and clear to all. Make sure this summary doesn’t degrade evidence and is compatible with regulations and advice.
Also, according to the current medical device regulation requirement, SSCP “should be translated into the languages accepted in the Member States where the device is envisaged to be sold.” This requirement includes both physicians and patients. So, take care to translate into all languages that apply without skipping English. Also, the SSCP document should specify in which language it was Notified body validated.
When you provide data that shows how much benefit you have for patients and how this comparison compares with other products and technology, the fewer questions the notified body asks you about the product. Please give the best objective facts and use quantitative data.
Start with high-quality documentation
SSCP must retrieve technical documentation already in place. An excellent SSCP can easily be written if a CER or PMCF is written with definite information about the device. Also, remember, you want to make notified body validation process easier!
Patient only part
For implantable devices with implant cards for patients, some devices from MDR Annex XVI, and class III devices used by patients, the SSCP should have a section dedicated for the patient with all relevant information.