In the EU IVDR 2017/746, there is a requirement to document and submit a Summary of Safety and Performance (SSP) for class C and Class D IVD. This is a new requirement compared to IVDD. The aim of SSP is to enhance transparency and provide public access to the data of safety and performance of IVDs.
In spite of this being a new requirement, Maven Profcon Services LLP has already prepared on SSP for their clients and developed best approach that you can follow for your submission.
SSP is advantageous for both the patient and healthcare professional as it is available on the public database patients can use it to research about the device and learn more about it. Healthcare professionals can use to understand safety and performance of the device already in market. However, note that the SSP is not intended to replace the IFU.
The SSP shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of SSP is submitted to Notified Body involved in the conformity assessment and shall be validated by that body. After its validation the NB uploads the SSP to EUDAMED and the manufacturer shall mention on the label and IFU where the SSP will be available.
The manufacturer is responsible for translation of the SSP to other official EU languages. If the SSP uploaded by NB is in language other than English then the manufacturer is responsible for translating it to English language is in a language other than English, then an English translation should be provided by the manufacturer and the NB will upload the English translation to EUDAMED.
The SSP must include the following:
- Identification of device i.e. Basic UDI-DI, and identification of manufacturer and single registration number
- Intended purpose, indication, contraindications, target populations
- Reference to harmonized standards and common specifications
- Summary of performance evaluation and relevant information of PMPF
- Description of the device and its accessories, including a reference to previous generations or variants
- suggested profile and training for users
- information on any residual risks and any undesirable effects, warnings and precautions
