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CDAQI research provides support for creating Summary of Safety and Clinical Performance document.

The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices.

The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudame.

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Summary of Safety and Clinical 8 Performance

  • The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN
  • The intended purpose of the device and any indications, contraindications and target populations
  • A description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device
  • possible diagnostic or therapeutic alternatives
  • reference to any harmonised standards and CS applied
  • The summary of clinical evaluation, and relevant information on post-market clinical follow-up
  • Suggested profile and training for users
  • Information on any residual risks and any undesirable effects, warnings and precautions

Best Practices for Writing a SSCP

Create a Template
  • Develop two different templates in line with the MDCG 2019-9 guide: one technical SSCP template for healthcare professionals, and a lay-friendly SSCP template for patients. Each template should align with the designated target audience in style, language, and literacy level. If you are required to submit both healthcare professional and patient sections, the SSCP template for healthcare professionals should precede the SSCP template for patients.
Keep the Audience in Mind
  • In the SSCP section for healthcare professionals, the consistent use of technical language with device-specific terminology and clinical context is appropriate. However, in the SSCP section for patients, avoid using technical jargon and medical terminology. In this section, use language at a U.S. 6th to 8th grade reading level, or at about a 12-year-old’s healthy literacy level. Clearly define medical terminology or replace it with lay-friendly language. Readability should be measured by a validated metric tool. Also consider having a patient advocacy group review the SSCP to determine comprehension.
Content and Tone of the Text
  • The content of the SSCP should enhance transparency and provide adequate access to product information for users. It should summarize all available clinical data for the device (favorable, unfavorable, and inconclusive). Align the SSCP content with the latest version of the device’s technical documentation. Technical sources to develop the SSCP may include the product’s IFU, design verification and validation reports, risk management report, clinical evaluation report, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) reports.
Localize the Content
  • An English version of the SSCP is required. The MDR also recommends translating the SSCP into the official languages of the EU member states where the device will be sold, as well as all languages required for IFUs in these member states. These translations should be subject to back translation to ensure accuracy.
Tabular and Graphical Presentation of Data
  • The content of the SSCP should enhance transparency and provide adequate access to product information for users. It should summarize all available clinical data for the device (favorable, unfavorable, and inconclusive). Align the SSCP content with the latest version of the device’s technical documentation. Technical sources to develop the SSCP may include the product’s IFU, design verification and validation reports, risk management report, clinical evaluation report, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) reports.Enhance readability by including quantitative data in tabulated lists of side effects and residual risks. Using simple infographics and figures can boost the device’s visual appeal and can help patient understanding. When using infographics, consider those with disabilities by using alternative texts and color contrasts, inverted colors, or inverted grayscale. Make sure a legal team carefully assesses any infographics to avoid promotional appearance.
Include Disclaimers
  • SSCPs aim to provide both favorable and unfavorable data for a device. To avoid misleading readers, add disclaimers to help clarify the purpose of the summary. Disclaimers should make it clear that the SSCP is not intended to give advice to treat a medical condition. For questions related to a medical condition or the use of a device, a healthcare professional should be contacted. Additionally, be sure to clarify that the SSCP does not replace an implant card or the IFU, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.
  • Since SSCPs will be publicly available as soon as Eudamed goes live, device manufacturers should focus on fulfilling the MDR guidance for SSCPs and verify the translations needed before bringing a device to the EU market. Though the delay in regulation may have brought short-term relief for manufacturers, the challenge remains to skilfully present all available device data for both healthcare professionals and patients.