The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Medical Device Regulation (EU) 2017/746 (hereinafter referred to as MDR and IVDR, respectively) have brought to the table several upgrades on medical devices, including the Summary of Safety and Clinical Performance (SSCP, MDR) or the Summary of Safety and Performance (SSP, IVDR). These documents aim to improve public access to data referred to high-risk devices through the EU database EUDAMED. Please consider keeping on reading this article to get more information about the topic.
What’s an SSCP/SSP?
An SSCP/SSP is an external document that incorporates information related to a medical device, such as general information, a summary of the clinical data collected from the device, or possible therapeutic alternatives. The main purpose of the SSCP/SSP is to provide both healthcare workers and patients access to current clinical, safety, performance and other types of data from the medical device; as this aligns with the MDR/IVDR philosophy of providing a more transparent and robust regulatory framework.
The SSCP is only required for implantable and class III medical devices (custom-made and investigational devices are excluded), whereas the SSP is required for class C and D IVDs. It must be prepared annually to comply with regulations, including possible updates from the Post-Market Clinical Follow-up (PMCF) and the Product Safety Update Report (PSUR) as part of the ongoing lifecycle of the device. Besides, the document must be submitted to and approved by a Notified Body (NB). NB validation focuses on verifying that all required sections are incorporated into the SSCP/SSP and confirming all the information is sourced from the device’s technical documentation.
After approval, the NB will upload the completed SSCP/SSP into the EUDAMED database, this way giving healthcare professionals and patients access to information that previously was limited to manufacturers and NBs. This update brings several benefits, as healthcare professionals will be more qualified to make specific decisions about patient care, and patients will be able to do research about the devices recommended by their healthcare providers. On the other hand, this surely presents a big challenge for manufacturers, who will be required to consider patients as a target audience.
What must my SSCP/SSP include?
One important premise to keep in mind is that the SSCP/SSP must be objective, as it should always include both favourable and unfavourable data. It should be based entirely upon the information contained in the technical documentation of the device and remain in constant revision to prevent the pertinent information from becoming outdated.
At a minimum, and according to MDCG 2019-9 – Rev.1, the SSCP should include sections that address:
- Device and manufacturer general details – including UDI details.
- Intended purpose.
- Indications, contraindications and target population.
- Description of the device, its components, medicinal products and any previous version of the device.
- Residual risk, warning and precautions details.
- Summary of the Clinical Evaluation of the device, emphasizing the PMCF evaluation and pointing out conclusions related to safety and performance.
- Description of necessary training and qualifications.
- Reference to harmonized standards and common specifications applied.
- Revision history.
Similarly, IVDs should address the same aspects when elaborating the SSP, including metrological traceability of assigned values. Consider reading the MDCG 2022-9, which provides a template for elaborating the SSP.
The SSCP/SSP should be available in English and the dominant language where the device will be sold. The manufacturer must ensure the translations are accurate (applying back translation is suggested at this point).
As mentioned before, the regulations include patients as intended recipients of the information in the SSCP/SSP only “if relevant”. In this case, relevant situations are translated as scenarios in which the devices are:
- Implantable devices for which patients will be given implant cards.
- Class III devices that are intended to be used directly by patients.
- Class C and D IVDs (SSP).
Given those cases, the manufacturer must provide two different versions of the SSCP/SSP: a version intended for professional users/healthcare professionals and a version specifically intended for patients or lay persons. It is recommended that the patient/lay person version is based on a lay-friendly SSCP/SSP template (also provided within the MDCG 2019-9 – Rev.1 for MDs and MDCG 2022-9 for IVDs); and that style, language and literacy levels are aligned with the designated target population. This should not be necessary for the SSCP/SSP section for professional users/healthcare professionals, in which technical jargon and medical terminology would be accepted.
Do patients really comprehend my SSCP/SSP?
Although it seems simple, targeting both professional healthcare and patient audiences will demand strong technical writing skills in your team, since it will be necessary to transform scientific data into easy-to-read content. Due to the complexity of this step, a readability test of the patient section is commonly performed to confirm correct comprehension.
When conducting a readability test, a specific amount of laypeople will be encouraged to go through the SSCP/SSP and respond to a questionnaire afterwards. Individuals taking the test should be representative of the final target population of the device. This type of readability test provides a statistical analysis of the difficulty of our document. The manufacturer should keep in mind that a NB can demand a readability test depending on the complexity of the SSCP/SSP submitted.
A clear and comprehensive version of the SSCP/SSP will help us achieve a successful readability test result. Some suggestions that will improve the patient understanding are:
- Clearly define medical terminology and, if possible, replace some terms with lay-friendly language; avoid acronyms.
- Include quantitative data related to parameters like side effects and residual risks.
- Make use of language equivalent to a 12-year-old’s healthy literacy level.
- Add figures, tables and infographics that boost the device’s visual appeal.
How can AKRN help?
The regulatory portfolio of implantable and Class III/Class C and D devices. Its production should only start after a proper analysis of guidelines related to the process. Here, in AKRN, we hold remarkable knowledge, experience and expertise in writing SSCP/SSPs and performing readability tests to ensure your success. Our team have gone through the entire process a significant number of times; therefore, we count on feedback from notified bodies, clients and internal sources.
Along with the development of an SSCP/SSP, there are several challenges the manufacturer will be faced with. Writing for technical and lay readers or publishing on EUDAMED – where the document will be available to the public – are some of the steps that put considerable pressure on getting the SSCP/SSP right. The manufacturer needs to ensure access to a level of medical writing expertise that guarantees comprehension of the SSCP/SSP content and consequently approval from a NB. AKRN is formed by a qualified team of dedicated professionals with sufficient medical communication experience to complete this task.
Our team can support you through SSCP/SSP development if you are still wondering how.
Subject Matter Experts
Beatriz Rodríguez, Ph.D. Regulatory Affairs Manager
Laura Martinez Campesino, Ph.D. Regulatory Affairs Scientist LinkedIn