Summary of Safety and Performance under EU IVDR

Clinical Performance Studies under the IVDR – What’s required, what has changed?

General Background

The Summary of Safety and Performance (SSP) is a summary document that provides an overview of the safety and performance for class C and D IVD devices in accordance with Art 29 of EU IVDR. The primary focus of the SSP is to summarize the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF to the intended audience.

The SSP includes information on the device’s intended use, performance, risks, and benefits, as well as any relevant clinical data. Relevant sections include:

1) SSP for devices not intended for self-testing

The manufacturer should address the collection and utilization of relevant sources including:

SSP Part A – summary intended for professional users

Additionally, based on the Article 83(3) of EU MDR, the gathered data should be used:

SSP Part B summary intended for patients/lay persons

2) SSP Template for devices intended for self-testing

The manufacturer should address the collection and utilization of relevant sources including:

SSP summary intended for public

For devices not intended for self-testing, the principal difference between Part A and Part B is the intended audience. Part B intended for patients should validate the language used to ensure readability by lay persons. For self-testing devices, the SSP is intended for public. The SSP should be provided in languages accepted in the Member States where the device is envisaged to be sold.

When drafting the summary of safety and performance it must be written in a way that is clear to the intended user and patient, if relevant. The SSP shall be part of the technical documentation body and validated by the notified body. After its validation, the notified body shall upload the summary to Eudamed. The label or instructions for use must indicate where the SSP is available.

The SSP must be updated regularly to reflect any new safety or performance information and must be provided to the notified body and the European Commission upon request.

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.

Key points

Key changes that require the manufacturer´s immediate attention:

SSP documents must be aligned with all aspects of the performance evaluation and holistic technical documents.
It is important to consider qualitative data regarding risk is expected to be presented in relation to time.
Readability and translation expectations should not be forgotten.
The SSP will be available via Eudamed. The manufacturer should have procedures in place to communicate updates to the published SSP document.

Our Services

Training

AKRA TEAM offers training to draft SSPs meeting the requirements of EU IVDR. Training includes a focus on both the considerations for Part A and Part B of the SSP document and how to avoid common findings raised during notified body review.

Process and Templates Development

AKRA TEAM has templates available for the SSP document including in-text guidance on what information should be included in each section in line with MDCG 2022-9.

Gap Assessment

AKRA TEAM performs gap analysis for SSP documents considering our extensive experience with notified body feedback and devices of all risk classes/types.

Implementation

We have available a team of clinical and regulatory experts who can draw up the SSP document for your device(s) based on the current technical documentation. AKRA TEAM can additionally support with updates needed in response to a notified body deficiency.

Continuous update of documentation

The SSP should be updated at least annually. AKRA TEAM can manage update timelines and SSP updates on behalf of the manufacturer to ensure continual compliance with the requirements of EU IVDR.

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