Article 29 of the IVDR requires manufacturers of Class C and D devices (except performance studies) to draw up a Summary of Safety and Performance. The SSP is written in a way clearly understood by the intended user and, where relevant, the patient, is validated by the notified body, and is made available to the public through EUDAMED. It covers the intended purpose, a summary of scientific validity and analytical and clinical performance, metrological traceability, residual risks, and the suggested profile and training of users.

Why it matters

The SSP is the IVDR counterpart of the MDR SSCP. It plays an important transparency role: hospitals, laboratories, and patients can review claimed performance and post-market findings for high-risk IVDs without accessing the technical file.

Common pitfalls

•Manufacturers often underestimate the effort required to make the SSP accessible to a lay audience, leading to documents that are too technical or use excessive jargon.
•Failing to adequately update the SSP throughout the device's lifecycle can lead to inconsistencies between the public document and the most current safety and performance data.
•Not obtaining proper notified body validation for the SSP before its publication can result in non-compliance and delays in market access or continued availability.

Sources

Regulation (EU) 2017/746, Article 29 · EUR-Lex
MDCG 2022-9 SSP Guidance · MDCG
IMDRF Documents · IMDRF

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