IVDR's Summary of Safety and Performance

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IVDRs 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
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Overview
Ensuring Compliance Understanding The IVDRs
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 Summar
y Of Safety And Performance (SSP)
Preparation? What Languages Should The Summary
Of Safety And Performance (SSP) Provide?
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Ensuring Compliance Understanding The IVDRs
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
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This post will unpack the Summary of Safety and Pe
rformance (SSP), explaining what it is, why it
matters, and what it contains.
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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
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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.
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Why Is Summary Of Safety And Performance (SSP)
Important?
It increases transparency by making data on the
IVDs performance publicly available. By having
this information readily available, healthcare
professionals can make more informed decisions
about using IVD in their practice.
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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.
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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.
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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
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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.
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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
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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.
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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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