The world of in vitro diagnostics is all about accuracy and reliability.
EU IVDR includes a requirement to write a
Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasise transparency and provide adequate public access to summarise the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable.
This blog post will unpack the Summary of Safety and Performance (SSP), explaining what it is, why it matters, and what it contains.
What is Summary of Safety and Performance (SSP)?
It provides key information about the device’s safety and effectiveness in an easy-to-understand format. This information is crucial for healthcare professionals and, in some cases, patients, to make informed decisions about using the IVD.
The data presented in the Summary of Safety and Performance (SSP) is compiled directly from the technical documentation. EU IVDR requires the Summary of Safety and Performance (SSP) to be validated by a Notified Body (NB), updated annually with new information and made available to the public via EUDAMED.
Why is Summary of Safety and Performance (SSP) important?
- It increases transparency by making data on the IVD’s performance publicly available.
- By having this information readily available, healthcare professionals can make more informed decisions about using IVD in their practice.
- For certain IVDs, the Summary of Safety and Performance (SSP) can empower patients to understand the test better and participate in shared decision-making with their healthcare provider.
What resources are required for Summary of Safety and Performance (SSP) preparation?
Summary of Safety and Performance (SSP) relies on already gathered information and technical documentation such as design and development, risk management, performance evaluation, post-market performance follow-up and post-market surveillance. If required, Instructions for Use can also be used as a source of information for preparing the Summary of Safety and Performance (SSP).
MDCG 2022-9 provides guidance for the preparation of the Summary of Safety and Performance (SSP), which has two sections:
- for devices intended to be used by professionals
- for devices intended for self-testing
Summary of Safety and Performance (SSP) for Devices Not Intended for self-testing:
It includes two subparts: one for professional users and another for patients/laypersons. If it is decided that a patient version/layperson is not applicable, then a justification must be provided.
Summary of Safety and Performance (SSP) shall include:
- Device identification and general information
- Intended use of the device
- Device Description
- Reference to any harmonised standards and CS
- Risks and warnings
- Summary of performance evaluation and post-market performance follow-up
- Metrological traceability of assigned values
- Suggested profile and training for users
- Revision History
Summary of Safety and Performance (SSP) is not intended to replace Instructions for Use as the main document to ensure safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users.
Summary of Safety and Performance (SSP) for self-testing devices:
Appropriate layperson terminology should be used throughout the document. Summary of Safety and Performance (SSP) shall include:
- Device identification and general information
- Intended use of the device
- Device Description
- Reference to any harmonised standards and CS
- Risks and warnings
- Summary of performance evaluation and post-market performance follow-up
- Metrological traceability of assigned values
- Suggested profile and training for users, if applicable
- Revision History
What languages should the Summary of Safety and Performance (SSP) provide?
Summary of Safety and Performance (SSP) should be prepared in languages accepted in the Member states, where the device is to be sold, along with an English version of the document. The language in which the Summary of Safety and Performance (SSP) was validated will be mentioned in the document.
References
Regulation (EU) 2017/746, MDCG 2022-9
