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Best Practices and Guidelines of compiling an effective Summary Of Safety And Clinical Performance (SSCP) for Medical Devices under EU MDR 2017/745

Updated: Apr 18


Safety And Clinical Performance (SSCP) for Medical Devices under EU MDR 2017/745

In the intricate landscape of medical device regulation, ensuring the safety and effectiveness of devices is paramount. Among the essential documents mandated by the European Union Medical Device Regulation (EU MDR 2017/745) is the Summary of Safety and Clinical Performance (SSCP). This concise summary encapsulates vital information about a medical device's safety and clinical performance, serving as a crucial resource for healthcare professionals and patients alike.

Here are the suggested best practices for crafting an effective Summary of Safety and Clinical Performance (SSCP) that adheres to regulatory standards and meets the needs of stakeholders.

  • Avoiding Replication: Resist the temptation to copy-paste content directly from technical documents. Instead, focus on distilling the essential information into a concise summary. This approach ensures clarity and facilitates understanding among users.

  • Ensuring Input Document Quality: The quality of the input document significantly impacts the effort required to compile the Summary of Safety and Clinical Performance (SSCP). Ensure that all input documents are prepared with meticulous detail, as this lays the foundation for an accurate and comprehensive SSCP.

  • Readiness of Input Documents: Before initiating the SSCP document, ensure that all input documents are readily available. These documents must be finalized and signed off by respective stakeholders, ensuring alignment and accuracy across all materials.

  • Consistency is Key: Maintain consistency across all sections and documents. Inconsistencies may lead to queries from Notified Bodies (NB) during regulatory review processes, potentially delaying approval timelines.

  • Translation Validation: Validate the accuracy of all translations to ensure that the SSCP is accessible to a global audience. Manufacturers are responsible for verifying the precision of translations, guaranteeing clarity and coherence across languages.

  • Regular Review Cycles: Implement annual review cycles to incorporate new information or changes relevant to the safety and performance of the device. These updates ensure that the SSCP remains current and reflective of the latest data and developments.