EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users, which includes both professionals and laypeople when applicable.
Although it’s new territory, RQM+ has already prepared SSPs on behalf of clients and developed best practices that you can follow for your own submissions.
Benefits of SSPs
SSPs benefit both patients and healthcare professionals. Because they are publicly available, patients can use SSPs to research IVDs recommended by healthcare professionals to learn more about the devices. Healthcare professionals can also use SSPs to better understand the performance data that has been used to support CE marking of the devices. It’s important to keep in mind, however, that these documents are not intended to replace the instructions for use as the main document to ensure safe use of the IVD.
Basics of SSPs
Although there is no specific guidance on SSPs other than the IVDR, the MDGC 2019-9 guidance on SSCPs under MDR can be used as a reference for what notified bodies (NBs) will expect. An SSP is a public document that must include general information about the IVD, a summary of performance data, and possible therapeutic alternatives. The data presented in the SSP is compiled directly from the technical documentation, including the performance evaluation report (PER) and periodic safety update report (PSUR). IVDR requires the SSP to be validated by a NB, updated annually with new information, and made available to the public via EUDAMED. NB validation includes confirming all required sections are included, determining whether all relevant information from the technical documentation is reflected in the SSP, and confirming that all information is sourced from the technical documentation.
After they have been verified by the NB and posted on EUDAMED (which will be digitally available in 2022), SSPs are visible to healthcare professionals, patients, and competitors. All SSPs must include a section written for professionals and, when relevant, a section written for patients.
According to Article 29 of IVDR, the SSP 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 generations or variants
- Reference to any harmonized standards and common specifications applied
- A summary of the performance evaluation and post-market performance follow-up
- The metrological traceability of assigned values
- Suggested profile and training for users
- Information on any residual risks and any undesirable effects, warnings, and precautions
Additionally, SSPs should:
- 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 PSUR since this is not a public document
- Include favorable and unfavorable data, and not include elements of a promotional nature
- Quantify the risks, including a relation to time, and specify the data source for each risk
- Acknowledge/address underreporting for vigilance-related quantitative data on side effects and residual risks if this data is reported in the SSP
- Include a discussion of any significant increase in frequency or severity of incidents and list any field safety corrective actions
- Discuss performance data of any equivalent devices separately from the data for the device
- Summarize the performance data for the device and discuss the benefit-risk ratio for each indication
When submitting an SSP, the NB must upload the SSP to EUDAMED within 15 days of validation. Within 90 days of validation of the master SSP, the manufacturer must provide translations for each member state in which the device is marketed. After validation, SSPs must be updated with the NB when necessary based on issues identified through post-market surveillance.
Best Practices for Writing SSPs
Although IVDR submissions are still relatively new in the industry, RQM+ has written SSPs for multiple clients and developed best practices based on our experience.
When elements of your technical documentation aren’t in alignment, the result is findings from the Notified Body. Much of the content in an SSP comes from the PER, so make sure the SSP template is aligned with the PER template.
One of the best practices used at RQM+ is continually updating templates when guidance documents are released and when we receive feedback from NBs. When you have updated templates for the SSP, PER, PMPF, and PSUR that are in alignment with each other, you can be confident that the same fundamental information is consistent across all technical documentation making it easier to create the SSP.
Balance transparency and confidentiality.
The intent behind the requirement for an SSP is to provide transparency for patients and professionals. Many manufacturers are initially resistant to the idea of sharing performance data, especially if it doesn’t always reflect positively on their products. However, it’s important to remember that much of the included information is already in the public domain through databases, scientific literature, and instructions for use. Manufacturers that have concerns about confidentiality with respect to competitors should remember that other manufacturers can already access that information through other sources besides the SSP.
Strike the right balance of content.
The SSP is like an executive summary—it should have enough information to be informative without overwhelming the reader. If too much detail is included, the document becomes more difficult to understand, making it less useful to patients and professionals. On the other hand, if too little detail is included, it doesn’t meet the spirit of transparency. Although we are still learning what balance NBs expect, our experience so far has shown that they are looking for a high-level summary with quantification of the data.
Pull from high-quality documents.
Because it is essentially extracted from other documentation, the quality of the source material plays a significant role in the quality of the SSP. When you have a well-written PER and IFU, pulling the information for the SSP becomes much easier. This alignment also makes it easier for the NB to validate the SSP.
Provide objective evidence.
NBs will look for quantitative data about the benefits, performance, and risks of the IVD to be provided in the SSP. This will provide patients and medical professionals with a clear and objective picture of the data used to support the safety and performance of your device. This will also limit the questions you will get from the Notified Body.
Write for the audience.
Writing an SSP is a regulatory requirement, but the intended audiences are patients and healthcare professionals, not regulators. Use plain language as much as possible, but be careful not to distort the evidence. The SSP should be easily understandable while staying in compliance with the regulations. You will also need to confirm that the SSP is written in a way that is clear to the patient, if applicable. Therefore, it’s important to build an assessment of the readability of the SSP into your process.
Select the right team.
Writing the SSP shouldn’t fall on the shoulders of a single individual, but should be a collective effort from a cross-functional team. In our experience, it is a joint effort between various teams with clear responsibilities:
- Clinical team: Write the performance evaluation and creating the SSP.
- Regulatory team: Extract the information from the IFU and technical documentation, review the SSP, and work with the NB to validate and upload the SSP.
- Risk management team: Confirm that the risks identified in the PER are appropriately listed in the SSP, IFU, and risk management documentation.
- Legal team: Review the SSP for legal issues.
- Marketing team: Review the SSP for consistency with marketing language.
Ideally, the person who is primarily responsible for writing the PER should write the first draft of the SSP.
Take the Next Step with RQM+
It’s not uncommon for IVD manufacturers to feel overwhelmed with all of the requirements under the new regulation, especially those with multiple product lines. That's why we created the IVDR Filtering Tool. Using this tool will enable you to easily filter lines of the IVDR by topic, chapter, section, article, and any search term, and view exact language from the IVDR Regulation (EU) 2017/746. If you need IVDR expertise or an implementation team, we are here when you need us.