The MDCG published a guidance document, specifically targeted at manufacturers and Notified Bodies, on the summary of safety and clinical performance (SSCP).
The MDR requires manufacturers to prepare a summary of safety and clinical performance for implantable devices and class III devices, other than custom-made or investigational devices. The SSCP is to be validated by a Notified Body, that will also make it available to the public via EUDAMED.
The guidance document issued by the MDCG provides guidance on presentation, content and validation of the SSCP, with specific regards to each of the required sections of the SSCP document. In fact, the Guidance further clarifies all the following aspects, that art. 32(2) of MDR requires to be included in the Summary:
- 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
This Guidance presents minimum mandatory content of the SSCP, yet the manufacturer can add further information from the Technical Documentation of the device without:
- affecting the readability of the SSCP and
- excluding any element of a promotional nature.
On the stylistic recommendations, the MDCG advises that the SSCP should be presented in an organised and unambiguous manner; it is recommended to keep the information for patients/lay persons and for intended users/healthcare professionals in two separate parts of the SSCP; abbreviations and acronyms should not be used; and should be written in a font type and size which allow easy reading.
The Guidance also reminds the manufacturers to review SSCP (and update) whenever PMCF and PSUR reports are updated; and states that the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold – in addition to the English translation; as well as to verify that the SSCP was uploaded to EUDAMED by the Notified Body before placing the device on the EU market.
The entire text of the document, including the Template for the SSCP can be found at this link.
More documents released by the MDCG can be found on MDLaw Library of Documents.
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