MDCG 2022 – 9 Rev. 1
15/4/2024
On 15th April 2024, the Medical Device Coordination Group (MDCG) published a document revising MDCG 2022 – 9. This revision adds some clarifications and further requirements to the existing safety and performance templates.
The main changes include:
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MDCG 2022-9 Rev.1 changes |
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Introduction |
Clarification on when the SSP should be made available to patients, elimination of footnote 3 |
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Footnote 2 |
In line with MDCG 2019-9 rev.2 |
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Section 1A |
“Indication whether it is a device for near-patient testing and/or a companion” moved from point 1.7 to point 2.3 |
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Section 1A, 1B and 2 |
”Intended use of the device” was replaced by ”Intended purpose and other indications” in point 2. |
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
Key points from the document:
- 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 be dedicated to the professional user.
- 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.
You can read the original document by clicking here
Our experts have created a Downloadable and ready-to-use SSP Template extracted from the document.
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