Summary of safety and performance Template – MDCG 2022-9
With the implementation of MDR and IVDR, a lot of emphasis is laid on safety and performance of the devices. Manufacturers, EU Authorised Representatives, notified bodies and all other players need to stay updated with the ever-changing regulatory landscape.
The IVD Regulations lay down a requirement for the manufacturer where they shall draw up a summary of safety and performance for class C and D devices. This summary needs to be validated by the notified bodies and be publicly available through EUDAMED.
The SSP should include information dedicated to the intended user, and if relevant, the patient. The SSP shall be kept updated in Eudamed.
If the device is not intended for self-testing, the SSP should have a first part dedicated to the professional user and the second for the end user/patient.
If the device is intended for self-testing, the SSP should be written in a way that is clear to the patients/lay persons, for instance taking into consideration the age of the targeted population.
This document is divided into 2 sections where
- Section 1 is SSP Template for devices not intended for self-testing
- Section 2 is SSP Template for self-testing devices
Our experts have extracted the template from the document and can be accessed by clicking here
While these templates ease out the work for manufacturers, there is a lot more than needs to be kept in consideration!
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