[co-author: Grégoire Paquet]
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation 2017/745 (MDR) which will enter into application in May 2020.
Article 32 of the MDR provides that for implantable devices and for Class III devices, other than custom-made or investigational devices, manufacturers shall draw up a SSCP. Once drafted, the SSCP shall be validated by the relevant notified body which will then make it available to the public via the European database on medical devices (Eudamed).
2. General requirements and recommendations for the SSCP
The Guidance includes a number of recommendations regarding the preparation of a SSCP. These include the following recommendations:
- The Guidance provides that the information contained in the SSCP must be sourced entirely from the technical documentation of the device.
- Annex XIV of the MDR provides that clinical evaluation must be thorough and objective, and take into account both favourable and unfavourable data. The Guidance provides that the SSCP must reflect this requirement.
- The SSCP must be written in a clear way and presented in an organised, consistent and unambiguous manner.
- The SSCP must always have one dedicated part for intended users/healthcare professionals, and if relevant a second part for patients. In addition, the SSCP must provide information at an appropriate depth to reflect the healthcare professionals’ and the patients’ different levels of knowledge. This includes the explanation of medical terms in simple language. In this regard, the Guidance recommends to give the lay term with a description first, and then the medical term afterwards.
- Where applicable, the SSCP should be translated into the languages accepted in the EU Member States in which the medical devices will be marketed. Similarly, if the selection of European languages for the SSCP does not include English, the Guidance provides that an English translation of the document should also be provided. Finally, each SSCP document should state in which language the SSCP was validated by the notified body.
- Regarding the validation of the SSCP by the notified body, the Guidance provides that when conformity assessment is performed according to Annex X and XI in the MDR and there are two notified bodies involved, it is the assessing notified body according to Annex X that shall validate the SSCP. The validation of the SSCP by the notified body must only cover one of the language(s) accepted by the notified body and agreed with the manufacturer.
- The manufacturer must keep the SSCP updated and provide this updated version to the notified body when required.
- Regarding Eudamed, the SSCP must be uploaded by the notified body, which is the only actor that can manage the SSCPs in Eudamed. The manufacturer must verify that the SSCP and any translations, if applicable, have been uploaded before placing a device on the EU market.
3. Specific requirements for the sections of the SSCP document
Article 32 (2) of the MDR provides the different elements that must appear in the SSCP. The MDCG’s document provides guidance on the content of each of the following required sections of the SSCP document:
- The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
- The intended purpose of the device and any indications, contraindications and target populations;
- A description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;
- Information on any residual risks and any undesirable effects, warnings and precautions;
- The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
- Possible diagnostic or therapeutic alternatives;
- Suggested profile and training for users;
- Reference to any harmonised standards and CS applied;
- Revision history.
The Guidance also includes a template for the SSCP.