What is Summary of Safety and Performance (SSP)?

The Summary of Safety and Performance (SSP) is a document required for medical devices under the European Union Medical Device Regulation (MDR 2017/745) which came into effect on May 26, 2021, particularly for high-risk devices (such as Class III and implantable devices). This document serves to provide a transparent and concise clinical evaluation and post-market monitoring system. The EMA helps oversee the regulation of medical devices within the EU, but the SSP is primarily an MDR requirement, which is more closely managed by national authorities and notified bodies rather than directly by the EMA. However, EMA’s guidelines influence the structure and requirements for the SSP.

What is the significance of Summary of Safety and Performance?

The SSP is a critical tool for ensuring that high-risk medical devices are both safe and effective throughout their lifecycle. By making key safety and performance data accessible, the SSP helps to:

• Improve regulatory transparency and accountability.
• Provide patients and healthcare providers with vital information to make informed decisions about device use. The SSP is intended to be publicly available, but for some devices, it will be made accessible via the EUDAMED database once the device is on the market.
• Facilitate post-market surveillance, helping to identify any issues or risks associated with the device once it is in the real-world setting.

What are the key elements included in the Summary of Safety and Performance?

• Device Description: A clear description of the device, including its intended use, target patient population, and any important technical specifications.
• Safety and Performance Data: A summary of the clinical and pre-clinical data that supports the safety and performance of the device. It must be demonstrated that the device meets the essential requirements set out in the MDR.
• Risk Management: A detailed account of the risk management processes, including identification of potential risks and how they have been mitigated to ensure safety throughout the lifecycle of the device.
• Post-Market Surveillance: Information on how the device will be monitored once it’s on the market, including post-market clinical follow-up (PMCF) or any planned post-market studies.
• Instructions for Use: A summary of the device's labeling and instructions for use (IFU), including any relevant warnings, contraindications, and necessary precautions.

What are the challenges associated with the Summary of Safety and Performance?

• Consistency and Quality of Data: The major difficulty is ensuring that the data presented in the SSP is consistent, accurate, and up-to-date.
• Interpretation of Complex Data: The SSP includes a wide range of information, such as clinical trial results, risk management processes, and real-world performance data. The agencies often face difficulties in interpreting these complex datasets, especially when they span multiple regions with varying regulatory standards.

Post-Market Surveillance and Risk Management

As part of the SSP, manufacturers are expected to provide up-to-date post-market surveillance data. The agencies must ensure that this data is both comprehensive and current, reflecting any new safety concerns or adverse events. The ongoing collection, analysis, and integration of post-market data into the SSP are complex, especially for devices that have been in the market for extended periods.

Adherence to Changing Regulatory Guidelines

With evolving regulations and guidance documents, the agencies must stay up-to-date with the latest MDR requirements and any updates to the European Medicines Agency (EMA) guidelines. This requires continuous learning and adaptation to ensure SSPs are compliant and meet the most current standards.

DDReg’s capabilities

At DDReg, we specialize in guiding manufacturers through the complexities of creating, interpreting, and submitting SSPs. From providing clear device descriptions to navigating the intricacies of post-market surveillance data, we ensure that your device meets all MDR requirements and is ready for the regulatory market.