Summary of Safety and Clinical Performance FAQ
Q: What is the Summary of Safety and Clinical Performance (SSCP)?
A: The SSCP is an external document
required under the EU Medical Device Regulation (MDR) for Class III and
implantable devices. It provides a comprehensive summary of the clinical data,
safety, and performance information for the medical device, aiming to improve
transparency and patient safety.
Q: Why is the SSCP required for Class III and implantable devices?
A: The EU MDR aims to establish a
more transparent and robust regulatory framework to limit future issues related
to medical devices. The SSCP requirement helps overcome difficulties physicians
faced due to device changes made without their knowledge, potentially impacting
patient care.
Q: Where can manufacturers find guidance on the SSCP?
A: The Medical Device Coordination
Group (MDCG) published MDCG 2019-9, which provides detailed guidance on the
presentation, content, and validation of the SSCP.
Q: How can healthcare professionals benefit from the SSCP?
A: Healthcare professionals can make
more informed decisions about patient care by using the objective and balanced
summary of clinical data provided in the SSCP.
Q: How can patients benefit from the SSCP?
A: Patients can conduct research more
easily on devices recommended by their healthcare providers, enabling them to
learn more about risks and undesirable effects and make more informed
decisions.
Q: What does the SSCP include?
A: The SSCP includes sections that
address device identification, intended purpose, device description, residual
risks, clinical evaluation summary, alternatives, user profile and training,
references to harmonized standards, and revision history.
Q: How is the SSCP compiled and validated?
A: Manufacturers compile the SSCP
from technical documentation, including the clinical evaluation report (CER)
and periodic safety update report (PSUR). The SSCP is then submitted to the
notified body for validation before being published in the Eudamed database.
Q: How should the SSCP be written?
A: While the SSCP is a regulatory
document, it is intended for healthcare professionals and patients. Therefore,
it should be written in plain language to be easily understood by both
audiences.
Q: Who should write the SSCP?
A: Various individuals should provide
input, and the document needs to be reviewed by appropriate individuals.
Ideally, the person who writes the CER should be involved in drafting the SSCP.
Q: How do manufacturers create a compliant SSCP?
A: Manufacturers should follow the
guidance provided by the MDCG and ensure alignment between the SSCP and
technical documentation. Creating and maintaining templates for consistency is
essential. The SSCP should strike a balance between providing enough detail for
understanding and being transparent while avoiding overwhelming the reader.
Quantitative data, benefits, risks, and comparisons to other devices should be
included.
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