With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established. For instance, as laid down in article 32, high-risk devices (implantable devices and class III devices) will have to include a summary of safety and clinical performance (SSCP), which will be publicly available on the MDR EUDAMED database. This summary must be submitted to the notified body involved in the conformity assessment, and shall be validated by said body.
Even though the MDR sets out the critical aspects that the SSCP should assess, it does not detail the content or the presentation style. In this sense, the Medical Device Coordination Group (MDCG) has endorsed a guidance document to assist both the manufacturers and the notified bodies in the preparation and validation of the SSCPs: https://ec.europa.eu/docsroom/documents/37323
Besides the specific content that should be included in the SSCP, this guidance document provides truly helpful information such as:
- Update frequency: since for this kind of devices the PMCF and the PSUR are meant to be updated at least annually, the SSCP shall also be reviewed and updated if needed to ensure that all the clinical and safety information is up to date.
- Format, structure and style: a template is provided to ease the preparation of the SSCP and stylistic recommendations are provided.
- Translation to EU languages: The SSCP should be translated into the languages accepted in the Member States where the device is to be sold. An English translation should also be provided.
- Information for patients: the specific scenarios where this information should be included (and its readability) are discussed.
¿Are you having doubts regarding how to draw up the SSCP of your device?
ASPHALION, an International Scientific and Regulatory Affairs Consultancy with extensive knowledge on the MDR and its related documentation, offers comprehensive support for the preparation of the documents necessary for your Medical Device.
Contact us at [email protected] to obtain specialized advisory and support with the preparation of the documentation for your MD.