Summary of Safety and Performance (SSP) Services for IVDR Compliance
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Confidently Navigate Summary of Safety and Performance (SSP) IVDR Requirements with NAMSA
In the evolving landscape of EU regulatory requirements, the Summary of Safety and Performance (SSP) IVDR is more than a checkbox, it’s your device’s public voice. For manufacturers of Class C and D IVDs, the SSP IVDR is a mandatory, high-visibility document that reflects your commitment to safety, performance, and transparency under the In Vitro Diagnostic Regulation (IVDR) 2017/746.
Quick facts about SSP IVDR requirements:
- Required for all Class C and D IVDs
- Mandated under IVDR 2017/746, Article 29
- Reviewed and validated by a Notified Body
- Updated annually or when significant changes occur
- Published on the EUDAMED database
- Must follow MDCG 2022-9 guidance
- Required in languages accepted by EU Member States
- Not required for devices used exclusively in performance studies
- Layperson section required for self-test devices
Making Your Device’s Safety and Performance Clear to All Audiences
The Summary of Safety and Performance (SSP IVDR) is a publicly accessible document that outlines your IVD device’s intended purpose, performance, and safety profile. It is designed to provide clear, non-promotional information to end users, healthcare professionals, and regulators via the EUDAMED database.
For devices intended for self-testing, the SSP must include a section written specifically for laypersons—which may include individuals with no scientific background, such as elderly users or even children, depending on the target population. This section must be written in plain, understandable language to ensure safe and effective use.
For example, a self-test IVD for blood glucose monitoring must clearly explain:
- What the device is for (e.g., monitoring blood sugar levels at home)
- How to use it safely
- What the results mean
- When to consult a healthcare professional
This level of clarity requires more than regulatory knowledge—it demands specialized writing skills and a deep understanding of the user experience. NAMSA ensures your SSP IVDR meets these expectations with precision and care.
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Want to learn more about our experience in IVDR? Wondering how long it will take, how we approach it and how much it will cost?
What Makes NAMSA the Right Partner
At NAMSA, we don’t just write summaries, we deliver regulatory clarity and submission confidence for your Summary of Safety and Performance documentation.
Our team has extensive experience working with Notified Bodies, ensuring your SSP IVDR meets expectations and avoids costly delays. We understand the nuances of IVDR compliance and how to present your device’s safety and performance in a way that is both scientifically sound and publicly accessible.
You’ll work with dedicated medical writers and IVD regulatory specialists who translate complex technical data into clear, compliant, and compelling summaries. Whether your device is for professional use or self-testing, we tailor the content to meet the needs of your audience—and the scrutiny of regulators.
Many manufacturers fall into the trap of copying content directly from the Performance Evaluation Report (PER) into the Summary of Safety and Performance. This approach often leads to rejections or delays. At NAMSA, we take a different path, crafting scientifically accurate, audience-appropriate summaries that meet regulatory expectations and resonate with the intended user. We also offer readability testing support when needed, helping you strengthen your submission and demonstrate your commitment to transparency and user safety.
Our SSP IVDR services are part of a comprehensive IVDR strategy, supporting you from performance evaluation through post-market surveillance. With NAMSA, you gain a partner who understands the full regulatory landscape and how to help you succeed within it.
Meet Our Team of Regulatory Experts
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Frequently Asked Questions (FAQ) About Summary of Safety and Performance (SSP)
Is the SSP required for all IVD devices?
No. The Summary of Safety and Performance is mandatory only for Class C and D IVD devices under the EU IVDR (2017/746). Devices used exclusively in performance studies are exempt. However, for all other Class C and D devices, the SSP must be submitted, validated by a Notified Body, and published in EUDAMED.
How often does the SSP need to be updated?
According to Article 56 (6), the Summary of Safety and Performance must be updated as soon as possible where necessary (e.g., when there are significant changes to the device, its performance, or safety profile; initiation or results of PMPF activity).
Is readability testing mandatory for the SSP?
Readability testing is not explicitly required by IVDR, but it is highly recommended—especially for self-test devices. Some Notified Bodies may request evidence that the layperson section is understandable.
What’s the difference between the Summary of Safety and Performance and the Performance Evaluation Report?
The PER is a confidential, technical document submitted to regulators, while the SSP is a public-facing summary. It must be written in clear, non-promotional language and tailored to the intended user—especially for self-test devices. Copying content directly from the PER is a common mistake and can lead to non-compliance.
Can the SSP be submitted before the technical documentation is finalized?
No. The SSP is part of the technical documentation package and must be consistent with the final version of your Performance Evaluation Report, risk management file, and labeling. It should be prepared once your core documentation is stable.
Can I use the same SSP for multiple similar devices?
Only if the devices are covered under the same Basic UDI-DI and share the same intended purpose, risk classification, and performance characteristics. Otherwise, a separate SSP is required for each unique device configuration.
