In 2017, the European Parliament and the Council of the European Union (EU) set a regulatory upgrade on medical devices to strengthen governance structure. This regulation update includes increased oversight of notified bodies, new requirements for transparency and traceability, and revised practices for clinical investigations, vigilance, and post-market surveillance.
While the new regulations on medical devices (MDR: Regulation [EU] 2017/745) and in vitro diagnostics (IVDR: Regulation [EU] 2017/746) aim to reduce risks associated with medical devices, their implementation calls for a focused effort from device manufacturers.
The COVID-19 pandemic delayed the enforcement of the MDR legislation until May 26, 2021. However, the transition is forcing manufacturers to make decisions to prepare for the new requirements.
One particular document presents a challenge for manufacturers, since they will need to consider patients a target audience. Article 32 of the MDR requires creating a summary of safety and clinical performance (SSCP), which device manufacturers will need to prepare annually to remain in compliance with the regulation.
The regulation (EU) 2017/745 requires device manufacturers to draft a summary of safety and clinical performances for implantable and class III medical devices, excluding custom-made or investigational devices. This SSCP will undergo validation by a notified body (NB) and will be publicly available via Eudamed, the EU database for medical devices. Manufacturers will submit the SSCP and periodic safety update reports (PSURs) to the NB and provide annual updates to align with the device’s technical documentation (TD). The SSCP is expected to be an important source of information for intended users, including healthcare professionals and patients.
For implantable devices that require patient implant cards and class III devices for patient use, the SSCP must include a section for patients. However, the SSCP should not give advice to diagnose or treat a medical condition nor replace any medical device document, such as the instructions for use (IFU) or the implant card.
Article 32 of MDR 2017/745 explicitly describes the requirements of the SSCP. For further guidance on the content and presentation of the SSCP, the European Union released MDCG 2019-9: Summary of safety and clinical performance, A guide for manufactures and notified bodies.
Here are the nine key elements that should be a part of the SSCP:
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.
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.
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.
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.
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.
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 skillfully present all available device data for both healthcare professionals and patients.
To learn more about how TransPerfect can help you write and translate your SSCP, contact email@example.com.