Implantable and Class III devices need to provide public access to a Summary of Safety and Clinical Performance (SSCP), according to MDR (EU) 2017/745.
The information in the SSCP should be sourced entirely from the technical documentation (TD) of the device, like design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports.
As the information from the CER, the SSCP shall be objective and adequately summarise both favourable and unfavourable data.
Importantly, the manufacturer needs to assign to the SSCP an identifier, or reference number, that is unique to this document and will remain the same for the entire lifetime of the SSCP. In combination with the manufacturer’s SRN this will allow for the unique identification of the SSCP in the EUDAMED database.
Furthermore, the Instructions for Use (IFU) shall contain all that is needed to directly find the SSCP in Eudamed; and, the SSCP needs to be kept updated. What this means is that when the PMCF evaluation report and the periodic safety update report (PSUR) are updated - at least annually, the SSCP shall also be reviewed and updated so that any clinical and/or safety information remains correct and complete.
Additionally, besides being provided in English – the common language of science nowadays, the SSCP needs to be translated into the languages accepted in the Member States where the device is going to be sold. This is to allow that not only health providers, but also patients, have access to the SSCP information. This is particularly important for implantable devices, where patients are given an implant card; and, class III devices that are directly used by patients.
In the case of such relevant devices, the information in the SSCP should be comprised of two parts separated by “page breaks”:
1. One part intended for users/healthcare professionals;
2. A second part for patients.
Each should provide information with different levels of knowledge and depth, since it is meant to be understood by the patient that does not have any basic knowledge in science or clinical research. As such, medical terms should be explained in simple language in the parts intended for patients; and, abbreviations and acronyms should be avoided as much as possible, and be clearly defined in the beginning of the text.Furthermore, the SSCP should be written in a font type and size that allows for easy reading, and provided has a PDF non-editable file.
The SSCP needs to be validated by a Notified Body (NB), particularly the one that assesses the Technical File; and, only one of the languages is assessed, given the promise from the manufacturer’s side that the translations are done precisely and accordingly. This validation depends on the class of the device and conformity assessment routes:
· For class III devices and class IIb implantable devices, except sutures and staples etc., the validation is performed when a draft SSCP is submitted to the NB involved in the conformity assessment, prior to issuing the certificate.
· For class IIa implantable and some IIb implantable devices such as sutures and staples etc., a draft SSCP submitted to the NB involved in the conformity assessment shall be validated by the NB.
The new Medical Device Coordination Group (MDCG) guidelines provide a recommended template for the SSCP, so that is easy for your medical writer to present its content for validation in a short amount of time.