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The requirement for a Summary of Safety and Clinical Performance (SSCP) was introduced along with the EU Medical Device Regulation (MDR) 2017/745 under Article 32 for implantable and Class III medical devices.
While the MDCG 2019-9 (Revision 1, March 2022) guidelines offer valuable direction, preparing the SSCP continues to present significant challenges. Navigating the complexities of compiling a comprehensive, compliant, and reader-friendly SSCP can be a daunting task for medical device manufacturers. Key challenges include striking the right balance between providing sufficient technical details and ensuring the document remains accessible to both healthcare professionals and the general public. Here, we have summarized best practices for successful SSCP development.
Follow the Latest MDCG Guidelines
Simple and effective. The MDCG guideline represents the best practices in the EU medical devices regulatory space, and therefore, Notified Bodies (NBs) consider their application essential for medical device evaluations. Sticking to the MDCG’s template regarding order and content can save you from some NB comments or non-conformities. It is also highly recommended to consult The European Association of Notified Bodies for Medical Devices (TEAM-NB) position paper (Revision 2, April 2023) on the MDR Technical Documentation, including specific guidance on the SSCP. As the representative organization of the majority of Notified Bodies in Europe, TEAM-NB’s input provides valuable insights into the expectations and best practices for compiling a comprehensive and compliant SSCP. Aligning the SSCP preparation with TEAM-NB’s recommendations can help ensure a smoother validation process with the designated Notified Body.
Harmonization Among Documents
The SSCP is based on information from the Clinical Evaluation Report (CER), developed in alignment with the data from the manufacturer’s Instructions for Use (IFUs), clinical investigations, post-market surveillance–including Periodic Safety Update Report (PSUR), and risk management documentation. Ensure that information is consistent across these sources, and when updating the CER, remember also to update the SSCP. Misalignment of information within the technical documentation is a common mistake auditors notice.
Make Sure the Content is Appropriate
The content of the SSCP is described in the regulation–manufacturers should only add what is strictly required. For instance, marketing information should be removed. Instead, the SSCP should collect safety and performance data and describe the Post-Market Clinical Follow-Up (PMCF) activities in place to collect clinical data and the current alternatives available to the corresponding medical device. Thus, the data presented should be transparent and unbiased, adequately weighing all the pros and cons of the device and alternatives. Additional information not aligned with the SSCP requirements can be spotted and highlighted as inappropriate by the NB.
Keep the Audience in Mind and Consider the Length of the Document
The SSCP is a publicly available document developed using a wide variety of documents containing complex data. As stated in MDCG 2021-1 Rev.1 (May 2021), until EUDAMED is operational, the SSCP should be provided to the public promptly upon request, or the manufacturer should specify where it is available to the public–typically on the website. Moreover, the SSCP section intended for patients should be provided in all the languages required for the IFUs that are provided to patients in the relevant Member States.
Keep in mind that the SSCP is for both healthcare professionals and, in some cases, patients. This especially applies to Class III devices used directly by patients or implantable devices for which an implant card is provided. It is unrealistic for healthcare professionals to carefully read a long SSCP for each medical device used or for laypersons to read complex medical vocabulary. Therefore, ensure that the SSCP is readable and that the length of the document is appropriate.
Consider Performing Readability Tests
As mentioned in the previous section, the data and results reported in the SSCP can be complex and challenging to follow. A NB will pay attention to that and subsequently ask for readability tests to ensure the intended audience understands the SSCP. There are different tools to test readability, including online tools and layperson readability tests performed on a group of volunteers (mirroring the device’s intended population) who read the SSCP and answer a questionnaire. NBs will also check how the readability test was planned and performed. Ensure you provide information on the document’s readability when submitting it to the NB, such as a dedicated Quality Management System (QMS) Standard Operating Procedure (SOP), mainly when the SSCP is directed to the patient. This procedure will assist in the validation of the SSCP by the NB.
General Tips
- The SSCP must be in a PDF format that is printable and searchable. It should adhere to the template outlined in MDCG 2019-9 last revision.
- Revisions should be performed on a yearly basis (as per Article 61), as required throughout the device’s lifetime, with any necessary updates clearly defined in the Post-Market Surveillance Plan.
- Remember to indicate the location of the SSCP in the IFU (e.g., website) and specify that it will be accessible on EUDAMED in the future.
- Every detail presented in the SSCP needs to be linked back to the technical documentation.
- Carefully select the data that must be included without any promotional content.
- Be concise and only include details when deemed necessary for the healthcare professionals and/or patients.
- Opt for quantitative data instead of qualitative descriptions.
- Include device images to help users and patients understand the device’s functionalities, but keep in mind that the SSCP is not intended to replace the IFU as the main document that will be provided to ensure the safe use of a particular device.
- Ensure the language and level of detail is adequate to each audience through a rigorous readability procedure.
- Coordinate with your NB to ensure the preferred languages for validation of the SSCP.
For more information on how to prepare SSCPs, you can also access NAMSA’s on-demand webinar here.