On September 27th the European Commission released MDCG 2019-9 Summary of safety and clinical performance – A guide for manufacturers and notified bodies. This document provides guidance on the presentation, content and validation of the Summary of Safety and Clinical Performance (SSCP) that needs to be drawn up by manufacturers of implantable devices and class III medical devices, other than custom-made or investigational devices, as per MDR 2017/745 Article 32.
Some of the key points addressed in MDCG 2019-9 are:
- The information in the SSCP should be sourced entirely from the technical documentation (TD) of the device. Examples of sources are 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.
- The manufacturer may add more information, than that what is minimally required, to enhance the comprehension of the mandatory information providing it does not affect the readability of the SSCP and it excludes any element of a promotional nature.
- The IFU must contain the necessary information on where to find the SSCP. This includes:
- A statement that the SSCP is available EUDAMED, where it is linked to the Basic UDI-DI.
- The URL to the EUDAMED public website: https://ec.europa.eu/tools/eudamed
- The Basic UDI-DI.
- The SSCP should be translated by the manufacturer into the languages accepted in the Member States where the device is envisaged to be sold. An English language version is always required. The manufacturer should ensure, through their quality management system, that the translations are correct.
- The SSCP should always have one part for intended users/healthcare professionals, and, when relevant, a second part for patients.
- For patients, the SSCP should inform them of any residual risks and side-effects with implantable devices for which they will be given implant cards and class III devices intended to be used directly by patients.
- For health professionals, the SSCP should provide an “objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device in question, whether favourable, unfavourable, and/or inconclusive,” among other information.
- The SSCP shall be uploaded in EUDAMED by the Notified Body.
The document contains a template for the SSCP that contains all the content requirements stipulated in the MDR in a structured way. It also provides guidance on how to complete each of the required sections in the template.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.