SSCP Safety and Clinical Performance
Safety and Clinical Performance (SSCP) is a document required for certain medical devices under the European Medical Device Regulation (EU MDR). It provides a comprehensive summary of the safety and clinical performance of a medical device, intended to be accessible to both healthcare professionals and the general public. The SSCP serves as a key component of the Technical Documentation required for CE marking and regulatory compliance in the European Union.
Key Components of the SSCP:
Device Description: The SSCP begins with a detailed description of the medical device, including its intended use, design features, and specifications.
Clinical Data: This section presents clinical evidence supporting the safety and performance of the device. It includes data from clinical investigations, post-market surveillance, literature reviews, and other sources.
Safety and Performance Characteristics: The SSCP outlines the safety and performance characteristics of the device, including any known risks, contraindications, and precautions.
Intended Population: Information about the intended patient population for the device is provided, including relevant demographics and clinical indications.
Instructions for Use: The SSCP includes instructions for healthcare professionals and end-users on the proper use, handling, and maintenance of the device.
Identification of Common Specifications: This section identifies any common specifications or standards applicable to the device, such as ISO standards for materials, manufacturing processes, and performance testing.
Relevant Standards and Regulations:
European Medical Device Regulation (EU MDR): The SSCP requirement is outlined in Article 32 of the EU MDR, which mandates that manufacturers of certain medical devices must provide a summary of safety and clinical performance as part of their Technical Documentation.
ISO 14155: Clinical Investigation of Medical Devices for Human Subjects: This ISO standard provides guidance on the design, conduct, and reporting of clinical investigations for medical devices, which may contribute to the clinical data included in the SSCP.
ISO 14971: Risk Management for Medical Devices: Manufacturers are required to conduct risk management activities in accordance with ISO 14971 and document the results in the SSCP. This includes risk analysis, evaluation, and mitigation strategies.
Clinical Evaluation Reports (CERs): The SSCP may reference data and findings from Clinical Evaluation Reports, which assess the clinical evidence supporting the safety and performance of the device.
Compliance and CE Marking:
The SSCP is a critical document for achieving and maintaining CE marking for medical devices under the EU MDR. It must be kept up-to-date with the latest clinical data and safety information throughout the lifecycle of the device. Failure to provide an accurate and comprehensive SSCP can result in non-compliance with regulatory requirements and may impact market access in the European Union.
In summary, the SSCP is a detailed summary of the safety and clinical performance of a medical device, required for regulatory compliance in the European Union. It provides essential information to healthcare professionals, patients, and regulatory authorities, ensuring transparency and confidence in the safety and effectiveness of medical devices on the market.
