The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements mandated for medical device manufacturers by The European Commission, as per the Medical Device Regulations (MDR, Article 32) for implantable devices and class III devices (other than custom-made or investigational devices, and as per (IVDR, Article 29) for class C and D devices, other than devices for performance studies. The SSCPs will be published on EUDAMED when it goes live on May 26, 2022. EUDAMED is the European Databank on Medical Devices. It is a collection of databases and electronic systems established by EU MDR for collecting data and will serve as an information system for exchanging legal information.
The core objective of the SSCP is to drive transparency and provide users with an updated summary of the device’s safety, clinical data, and clinical performance. The SSCP is developed using the technical documentation for the device, including the clinical evaluation report (CER), post-market surveillance, and post-market clinical follow-up (PMCF), and needs to be updated when the PMCF and PSUR are updated. The SSCP must also be validated by a Notified Body (NB), which will then upload it on EUDAMED, with regular updates annually. SSCPs not only help share information with the public, but also allow manufacturers a more in-depth understanding of the competitive landscape and help build their case.
The SSCP needs to include two sections, addressing healthcare professionals and patients, respectively. It contains nine sections, and covers diverse aspects including the intended use, indications, contraindications, the device description, alternatives, training, a summary of the clinical evaluation and PMCF, revision history, reference standards, and more.
Authoring these documents requires strong technical and scientific writing skills, and the ability to present data in an objective manner, targeted to diverse audiences. Importantly, the Medical Device Coordination Group (MDCG) guidance requires translations of SSCPs to be included the manufacturer’s Quality Management System (QMS). Once the NB has validated the SSCP, the manufacturer needs to translate the SSCP into all relevant EU languages. If the Master SSCP was validated in a European language, the manufacturer needs to provide an English translation, which then needs to be provided to the NB within 90 days of the Master SSCP being uploaded. After, the NB must then upload this on EUDAMED within 15 days. The translated summaries should be available in EUDAMED in the local language prior to the product being distributed for sale. The NB does not need to be validated, but does need to be uploaded on EUDAMED within 15 days of receipt from the manufacturer.
CSOFT Health Sciences offers expertise in authoring and translating SSCPs, by:
- Providing experienced scientific and technical writers to author SSCPs with the ability to tune in to audiences with varying health literacy levels
- Providing native, in-country translators with niche expertise in translating medical device documentation to support rapid translations of the SSCPs and allied documents to ensure compliance with EU MDR / IVDR requirements