Summary of Safety and Clinical Performance (SSCP) Services for MDR Compliance
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Of Our Writers Hold Advanced Degrees (MSc, PhD, MD)
Consultants with Previous EU Notified Body Experience
Medical Device Clinical and Regulatory Specialists on Staff
Navigate Summary of Safety and Clinical Performance (SSCP) MDR Requirements with NAMSA
The Summary of Safety and Clinical Performance (SSCP) is a mandatory, publicly accessible document under the EU Medical Device Regulation (MDR 2017/745) for all Class III and implantable devices. It is designed to provide transparent, scientifically sound information to patients and healthcare professionals, and it must be written with both audiences in mind. At NAMSA, we help you develop SSCPs that are accurate, accessible, and aligned with regulatory expectations, while also supporting your market success.
Quick facts about Summary of Safety and Clinical Performance requirements:
- Required for all Class III and implantable devices
- Mandated under MDR 2017/745, Article 32
- Reviewed and validated by a Notified Body
- Updated at least annually or when significant changes occur
- Published on the EUDAMED database
- Must follow MDCG 2019-9 guidance
- Required in languages accepted by the EU Member States where the device is sold
- Two versions may be required: one for healthcare professionals and, if relevant, one for laypersons too
Your Trusted Partner for Summary of Safety and Clinical Performance Development
At NAMSA, we understand that the SSCP MDR isn’t just another regulatory deliverable, it’s a public-facing document that reflects your clinical credibility and brand integrity. Our team of regulatory consultants, clinical experts, and medical writers works closely with you to develop SSCPs that are scientifically accurate, clearly written, and fully aligned with MDR and MDCG 2019-9 guidance.
We support the full process, from extracting the right data from your Technical Documentation to crafting both the professional and layperson versions of the SSCP. For lay SSCPs, we apply validated readability testing tools to ensure your content is accessible to patients, including those with limited health literacy.
Whether you’re preparing your first Summary of Safety and Clinical Performance or updating an existing one, NAMSA delivers the clarity, compliance, and confidence you need to succeed in today’s transparent regulatory environment. Our team has deep experience working with Notified Bodies, ensuring your Summary of Safety and Clinical Performance meets expectations the first time, avoiding costly delays or rework.
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Meet Our Team of Regulatory Experts
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Beatriz Rodriguez Grande, PhD
Regulatory Consultant and Consulting ManagerView Bio -
Matt Royle, PhD
Principal Regulatory ConsultantView Bio -
Jane Arnold-Round, MSc
Senior Principal Consultant, RegulatoryView Bio -
Kevin Butcher
Principal Regulatory ConsultantView Bio -
Rachel Gibbs, BSc, PhD
Principal Regulatory ConsultantView Bio -
Thomas Miramond, PhD, MSc, M-Eng.
Senior Regulatory ConsultantView Bio
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EU Technical Documentation
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Frequently Asked Questions (FAQ) About Summary of Safety and Clinical Performance (SSCP)
What is Summary of Safety and Clinical Performance?
The Summary of Safety and Clinical Performance (SSCP) is a mandatory document under the EU MDR (2017/745) for all Class III and implantable medical devices. It provides a public-facing summary of a device’s clinical performance, safety profile, and intended use, and is published in EUDAMED for access by healthcare professionals, patients and regulators. The SSCP must be written in a clear, non-promotional format.
Who is required to submit an Summary of Safety and Clinical Performance?
The SSCP is mandatory for all Class III and implantable medical devices under the EU MDR (2017/745). If your device falls into either category, you must prepare and maintain an SSCP as part of your technical documentation.
Do I need to create a layperson version of the Summary of Safety and Clinical Performance?
If your device is implanted or used directly by patients (e.g., implants or home-use devices), you must provide a layperson version of the SSCP. This version must be written in plain language and validated for readability to ensure it can be understood by non-experts. NBs will also check how the readability test was planned and performed.
What content must be included in the SSCP?
The SSCP must include:
- Device and manufacturer identification
- Device description, Intended purpose, indications, contraindications, target population
- Information on residual risks and warnings
- Summary of the Clinical Evaluation with relevant PMCF information
- Diagnostic or therapeutic alternatives
- User profile and training requirements
- Standards and Common Specifications applied
- Revision history
How often must the SSCP be updated?
The SSCP must be reviewed and updated at least annually, or whenever new clinical data or significant changes to the device occur. Updates must be aligned with the CER and PMCF reports.
What’s the difference between the SSCP and the Clinical Evaluation Report (CER)?
The CER is a confidential, in-depth technical document submitted to regulators. The SSCP is a public-facing summary of that data, written in a clear, accessible format for healthcare professionals—and in some cases, laypersons. It must be understandable, non-promotional, and scientifically accurate.
