SSCP Writing Support
Summary of Safety and Clinical Performance for Class III Devices
For Class III and implantable devices requiring an SSCP under EU MDR. We write content that is clearly structured, aligned with clinical documentation, and appropriate for both healthcare professional and patient audiences.
Who This Is For
When You Need SSCP Support
First SSCP for a Class III device
Your device is Class III or a relevant implantable and you need an SSCP written from scratch — structured for both healthcare professional and patient audiences, aligned with your CER.
SSCP not aligned with updated CER
Your CER has been updated — new clinical evidence, revised benefit-risk conclusions, or changed intended purpose — and the SSCP now needs to be brought into alignment before your next NB review.
NB observations on the SSCP
Your Notified Body has flagged the SSCP — for inconsistencies with the CER, inadequate patient language, or missing clinical data sections. Structured revision is required.
EUDAMED upload preparation
Your SSCP is drafted but needs a completeness and formatting check before EUDAMED submission — including plain language review of the patient-facing section.
Context
What Makes SSCP Writing Distinctive
Who must produce an SSCP?
Manufacturers of Class III devices and implantable Class IIb devices under EU MDR are required to produce and maintain an SSCP, uploaded to EUDAMED and updated with each CER revision.
What makes an SSCP non-compliant?
Common NB observations include: patient section not in plain language, HCP section not aligned with CER benefit-risk conclusions, missing post-market data, and inconsistencies with device description or intended purpose.
How does the SSCP relate to the CER?
The SSCP is essentially a structured public summary of the clinical evaluation. It must reflect the CER's clinical evidence, benefit-risk analysis, and conclusions — updated whenever the CER is updated.
What We Deliver
SSCP Deliverables
Every SSCP engagement produces a document that satisfies EU MDR Article 32, MDCG 2019-9, and Notified Body review expectations — structured for clarity, EUDAMED upload readiness, and full alignment with your clinical documentation.
Mandatory for Class III devices. Also required for implantable Class IIb devices that are not custom-made or investigational.
Included
- Healthcare professional section — clinical performance, safety data, benefit-risk summary
- Patient-facing summary in plain language appropriate for lay readers
- Clinical benefit-risk summaries aligned to the CER benefit-risk conclusions
- Intended purpose and device description section
- CER and PMCF data alignment check — consistency across all clinical documentation
- EUDAMED-ready structure and plain language review
Our Approach
How We Write an SSCP
The challenge of SSCP writing is that the same clinical information must be communicated to two audiences with completely different needs. We resolve this by writing each section for its intended reader — not by producing a single generic document.
CER Alignment Review
We read the current CER — clinical evidence, benefit-risk conclusions, intended purpose, and residual risks. The SSCP must reflect these precisely. We identify alignment gaps before writing.
Audience Mapping
The SSCP must work for two distinct audiences: healthcare professionals who need technical precision and patients who need clarity. We structure the document for both — not a single generic voice.
HCP Section Writing
We write the healthcare professional section with clinical precision — device description, clinical performance data, safety profile, benefit-risk analysis, and relevant post-market data.
Patient Summary Writing
We write the patient-facing summary in plain language — no regulatory jargon, appropriate reading level, and structured to answer the questions a patient would actually have about the device.
Consistency Check
We verify that all clinical data, benefit-risk conclusions, and intended purpose statements are consistent across the SSCP, CER, IFU, and PMCF documentation before final delivery.
Related Services
The SSCP must align with the CER and PMCF data. If either needs updating, that work typically precedes or runs in parallel with SSCP writing.
Ready to discuss your SSCP?
Tell us your device class, current CER status, and EUDAMED timeline — we will scope the engagement from there.