EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
Origin of SSCPs
As with many regulatory requirements, the EU MDR came about as a result of real-world challenges and several well-publicized medical device failures. The EU MDR aimed to limit future issues by providing a more transparent and robust regulatory framework. This included, in part, the requirement for manufacturers to make an SSCP publicly available for their Class III and implantable devices. This provides a level of transparency similar to pharmaceutical products and Class III devices in the U.S. and gives patients and healthcare professionals access to information that was previously only available to manufacturers and notified bodies.
To provide further guidance on the presentation, content, and validation of the SSCP, the Medical Device Coordination Group (MDCG) published MDCG 2019-9, titled “Summary of safety and clinical performance: A guide for manufacturers and notified bodies,” in August 2019. This goes into much more detail than the EU MDR and includes a significant amount of information intended to overcome difficulties physicians had as a result of device changes made without their knowledge that potentially impacted patient care. In the end, the goal is to improve the health and safety of patients.
Benefits of SSCPs
One benefit is that healthcare professionals can use the data from SSCPs to make more informed decisions about patient care by providing them with an “objective and balanced summary” of the clinical data. Another benefit is that patients can more easily do research about the devices recommended to them by their healthcare providers. By empowering patients to learn more about the risks and undesirable effects, they can also make more informed decisions.
Basics of SSCPs
An SSCP is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and a summary of possible therapeutic alternatives.
The SSCP data is compiled directly from the technical documentation, including the clinical evaluation report (CER) and periodic safety update report (PSUR).
The SSCP must be validated by a notified body (NB), updated annually with new information, and made available to the public via Eudamed. The NB validation includes confirming that all required sections are included in the SSCP, verifying whether all relevant information in the technical documentation is reflected in the SSCP, and confirming that all information in the SSCP is sourced from the technical documentation.
When complete, SSCPs are visible to healthcare professionals, patients, and competitors. They include a section written for professionals and, when relevant, a section written for patients. It must be written so that it is clear to the intended user and, if relevant, to the patient. MDCG 2019-9 also recommends that the readability of the patient section is confirmed using a readability test given to laypeople or using another adequate method.
The SSCP must include sections that address:
- Identification of the device and the manufacturer, the basic UDI-DI, and the single registration number (if it has already been issued)
- Intended purpose, indications, contraindications, and target populations
- Description of the device and its accessories, including a reference to previous generation(s) or variants
- Information on any residual risks and any undesirable effects, warnings, and precautions
- A summary of the clinical evaluation and post-market clinical follow-up
- Possible diagnostic or therapeutic alternatives
- Suggested profile and training for users
- Reference to any harmonized standards and common specifications applied
- Revision history
Additionally, SSCPs should:
- Use the template provided in MDCG 2019-9
- Be associated with one and only one basic UDI-DI
- Be submitted in English and the manufacturer’s language
- Be sourced entirely from the technical documentation; it can reference the instructions for use (IFU), but not the periodic safety update report (PSUR)
- Include the expected lifetime information for nonabsorbable implants along with implant survival rates
- Include favorable and unfavorable data and not include elements of a promotional nature
- Quantify risk with relation to time and describe the data source
- Acknowledge/address underreporting for vigilance-related quantitative data on side effects and residual risks
- Include a discussion of any significant increase in frequency or severity of incidents and list any field safety corrective actions
- Discuss clinical data of any equivalent devices separately from the data for the device
- Summarize the clinical data for the device and discuss the benefit-risk ratio for each indication
Requirements for the SSCP submission process include:
- Uploading all SSCPs to Eudamed at the time of initial certification (NB does this within 15 days of validation)
- Providing translations for each member state in which the device is marketed within 90 days of validation of the “master” SSCP (NB does not validate translations)
- Sending an update to the NB if it’s required based on PSUR outputs
SSCP documents will be available digitally in 2022 when Eudamed rolls out.
8 Lessons Learned About SSCPs
RQM+ began drafting SSCPs before official guidance was published in August 2019, so our processes—and the expectations of the notified bodies—have evolved. Although the industry is still in the early stages of writing SSCPs, there are already many lessons to share.
1. Closely follow the guidance as written.
Take steps to ensure that the SSCP and technical documentation align and include all sections and relevant quantitative data outlined in the guidance. A signature from the person responsible for regulatory compliance (PRRC) may also be required by the notified body. Remember that the guidance represents the best practices (and bare minimum). Notified bodies treat it as such and so should manufacturers.
2. Create and update templates.
Misalignment between the PMS, risk management, instructions for use, and clinical evaluation can create problems when writing the SSCP. In particular, the clinical evaluation templates should be updated to ensure that the information needed to complete the SSCP is easily available within the CER.
At RQM+, we continuously learn from each other to build our collective knowledge. This includes creating and updating templates when we get feedback from notified bodies or new guidance documents are published. We recommend developing templates for the SSCP, CER, PMCF, and PSUR so that the same fundamental information can be shared across all technical documentation to ensure alignment.
3. Balance confidentiality and transparency.
Although manufacturers may be reluctant to share all of their clinical data—especially the data related to residual risks and undesirable effects—the intent behind the SSCP requirement is to be as transparent as possible so clinicians and patients can understand risks and make informed decisions. It’s also important to keep in mind that the data coming from the IFU, literature, and post-market databases are already in the public domain so other manufacturers most likely already have access to this information through other sources.
4. Think of the SSCP as an executive summary.
Although manufacturers and notified bodies will have different preferences regarding how much detail to include, we have found that there is a balance between providing too much and not enough. Too much detail misses the mark on the intent for the information to be easily understood, while too little defies the intent to be transparent. As with our experience in writing other types of technical documentation such as CERs, we expect to quickly calibrate as we continue to work with manufacturers and notified bodies. Based on what we have seen so far, notified bodies are expecting a high-level summary with quantification of the data similar to an executive summary.
5. Start with high-quality documentation.
The SSCP must extract information from the technical documentation that already exists. It’s much easier to write an SSCP if you already have a well-written CER and IFU with a clear description of the device, intended use, indications for use, benefits, and residual risks. Keep in mind that this will also make it much easier for the NB to validate the content in the SSCP.
6. Be specific.
The more quantitative data you can provide about the benefits and risks of the device, how you know that patients will benefit from the device, and how it compares to other devices, the fewer questions you will get from the notified body. Provide as much objective evidence as you can.
7. Use plain language.
Although the SSCP is a regulatory document, the intended audiences are healthcare professionals and patients so it should be written as such with minimal regulatory language. Ensure that the summary doesn’t distort the evidence and that it complies with the regulations and guidance but is also easily understandable by the intended audience.
8. Assign the right people.
Although there is no specific guidance about who should compile and write the SSCP, it should involve more than a single person and needs to be reviewed by the appropriate individuals. In our experience, it is a joint effort between the:
- Clinical team who writes the clinical evaluation and does the hands-on work creating the SSCP
- Regulatory team who extracts the information from the instructions for use and technical documentation, confirms that the guidance has been adequately followed, and works with the NB to validate and upload the SSCP
- Risk management team who confirms that the risks identified in the CER are appropriately listed in the IFU and risks management documentation
- Legal team who reviews the SSCP for legal issues
- Marketing team who reviews for consistency with marketing language
When possible, the person who writes the CER is typically the best person to write the first draft of the SSCP.
Benefit from Our Experience
RQM+ has created hundreds of technical documentation files, including SSCPs and CERs. We’ve also gone through the entire process, having received notified body feedback on files that our clients submitted to notified bodies. We have the knowledge, proven processes, and evolving expertise to ensure your success.
If you’d like to learn more about how our team can help guide you through SSCP requirements, contact us today.