Aligning with Medical Device Regulation (MDR) for Improved Information Accessibility
In accordance with the Medical Device Regulation (MDR) 2017/745, which emphasizes increased transparency and easy access to vital information, DeSia offers comprehensive services for preparing the Summary of Safety and Clinical Performance (SSCP) for implantable and class III devices. This critical document is not only a regulatory requirement but also a key tool in communicating the safety and efficacy of medical devices to health professionals and patients alike.
Crafting a Detailed and Informative SSCP
We ensure that the SSCP comprises detailed data on the safety and clinical performance of the device, along with an up-to-date summary of clinical data.
Sourcing Information for Comprehensive Reporting
The information compiled in the SSCP is meticulously sourced from:
- Design Verification Reports: Documenting the design and development process of the medical device.
- Risk Management Report/File: Detailing the assessment and management of potential risks associated with the device.
- Clinical Evaluation Report: Summarizing the clinical evaluation and findings.
- Post-Market Surveillance (PMS) and PMCF Plans and Reports: Providing ongoing data on the device's performance and safety post-market.
Regular Updates for Continued Compliance
Consistent with the dynamic nature of medical device regulations, we ensure that the SSCP is regularly updated. This involves revising the document in line with updates to the PMCF report and Periodic Safety Update Report (PSUR), at least annually, to maintain the accuracy and completeness of clinical and safety information.
Partner with DeSia for SSCP Preparation
To receive expert assistance in preparing a Summary of Safety and Clinical Performance (SSCP), please get in touch with us. Contact DeSia by sending a mail to info@desiaclinical.com to ensure your medical devices meet the regulatory standards of transparency and patient safety.
Aligning with In Vitro Diagnostic Regulation (IVDR) for Enhanced Data Transparency and Accessibility
In parallel with the Medical Device Regulation (MDR) 2017/745's initiative for increased transparency and easy access to critical medical device information, DeSia extends its comprehensive services to include the preparation of the Summary of Safety and Performance (SSP) for in vitro diagnostic (IVD) medical devices under the In Vitro Diagnostic Regulation (IVDR) 2017/746. Specifically focusing on high-risk Class C and Class D IVDs, the SSP becomes a crucial document ensuring that health professionals and patients have access to essential safety, performance, and clinical data.
Crafting a Detailed and Informative SSP for High-Risk IVDs
We ensure the SSP contains a comprehensive summary covering the IVD's safety and performance data. This includes detailed analytical and clinical performance data, highlighting the IVD's intended purpose and providing clear instructions for its use, especially given the elevated risk profile of Class C and D devices.
Sourcing Information for Comprehensive Reporting
To ensure the SSP for Class C and D IVDs is thorough and reliable, we meticulously compile information from:
- Analytical Performance Reports: These documents are critical for illustrating the device's diagnostic accuracy, including sensitivity, specificity, and predictive values, which are paramount for high-risk IVDs.
- Risk Management Report/File: Detailing comprehensive risk assessment and mitigation strategies tailored to the higher risks associated with Class C and D IVDs.
- Scientific Validity Report: Demonstrating the scientific basis and clinical relevance for the IVD's intended use, this report is vital for high-risk classifications to ensure clinical efficacy and patient safety.
- Post-Market Performance Follow-up (PMPF) Plans and Reports: For Class C and D IVDs, ongoing performance and safety data are crucial. These reports provide valuable insights into the real-world application of the IVD, informing necessary updates or modifications.
Regular Updates for Continued Compliance
Given the dynamic nature of IVD regulation and the particular scrutiny on high-risk devices, DeSia ensures the SSP for Class C and D IVDs is regularly updated. This reflects any changes in risk assessment, device functionality, or the post-market performance landscape, maintaining the document's accuracy and comprehensiveness for health professionals and patients.
Partner with DeSia for SSP Preparation
For expert assistance in preparing a Summary of Safety and Performance (SSP) that meets the IVDR's stringent requirements for Class C and D IVDs, ensuring your high-risk devices are presented with transparency and thoroughness, contact DeSia. Email us at info@desiaclinical.com for guidance through the regulatory intricacies and support in maintaining the highest standards of patient safety and device efficacy.
