Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. 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. https://mavenprofserv.com/understanding-the-ivdr-summary-of-safety-and-performance/

1. IVDR’s Summary of Safety and
Performance (SSP)
W W W . M A V E N P R O F S E R V . C O M

2. O v e r v i e w
Ensuring Compliance: Understanding The IVDR’s Summary Of Safety And
Performance (SSP)
What Is Summary Of Safety And Performance (SSP)?
Why Is Summary Of Safety And Performance (SSP) Important?
What Resources Are Required For Summary Of Safety And
Performance (SSP) Preparation?
What Languages Should The Summary Of Safety And Performance (SSP)
Provide?

3. Ensuring Compliance: Understanding The IVDR’s
Summary Of Safety And Performance (SSP)
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 emphasize transparency and provide adequate public
access to summaries the data on safety and performance to
patients and intended users, which includes both professionals
and lay people where applicable

4. This post will unpack the Summary of Safety and Performance
(SSP), explaining what it is, why it matters, and what it contains.

5. What Is Summary Of Safety And Performance (SSP)?
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 emphasize transparency and provide
adequate public access to summaries the data on safety and
performance to patients and intended users, which includes
both professionals and lay people where applicable

6. 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.

7. 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.

8. 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.

9. 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.

10. 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

11. 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.

12. 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

13. 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.

14. 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.

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