Summary of Safety and Clinical Performance (SSCP) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Article 32
Summary of Safety and Clinical Performance (SSCP) Template — EU MDR
The Eudamed-published document for Class III and implantable devices, with the professional and lay sections kept distinct throughout, as Article 32 requires.
One document, two readers, one register
The SSCP has to work for a patient reading it on Eudamed with no clinical background, and for a healthcare professional reading the same document for a technical summary. Written in one register, it either reads as jargon to the patient or as a watered-down summary to the professional — and MDCG 2019-9 Rev.1 expects the two sections clearly distinguished, not blended.
An SSCP that works separates the professional and lay content structurally, so each reader finds their own section, at their own level, without the other getting in the way.
None of this is difficult. It is the consequence of writing for an average reader who does not exist.
- Word .docx
- Fully editable
- README included
- Instant download
- Class III and implantables
Scope
What the template covers
Every element MDCG 2019-9 Rev.1 requires, structured for direct Eudamed publication.
01
Professional and lay sections
Professional and lay sections clearly distinguished throughout, with device identification and intended use covered in both registers.
02
Device and risk description
Device description, accessories and combinations, plus residual risks, warnings and precautions in patient-appropriate language.
03
Clinical evidence and Eudamed profile
A summary of clinical evaluation and PMCF outputs, the intended clinical benefits, and a suggested profile for Eudamed publication.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs managers preparing Class III or implantable device documentation
- Manufacturers whose current SSCP blends professional and lay content
- Consultants preparing a device profile for Eudamed publication
The template assumes a Clinical Evaluation Report and PMCF outputs already exist to summarise. It does not teach Article 32: it gives you a document already split into the two registers Eudamed publication requires.
What is included
What you get when you buy
- 1 Microsoft Word .docx file, fully editable
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Is this required for every device?
No. Article 32 requires an SSCP only for implantable devices and Class III devices, other than custom-made or investigational devices.
Does this template reference the CER?
It summarises the CER’s clinical evaluation and PMCF outputs rather than reproducing them; you need the CER and PMCF Evaluation Report to complete those sections.
Is this the whole clinical file?
No. This is one of eight coordinated documents. It publishes a summary of what the other seven establish.
Can I buy the full kit instead?
Yes. This template is one of eight in the EU MDR Clinical Documentation Kit, priced at €399 against €552 buying all eight separately.
What software do I need?
Microsoft Word, or a compatible alternative that opens .docx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full clinical lifecycle?
This template is one of eight in the coordinated kit.
The EU MDR Clinical Documentation Kit ships this summary alongside the CEP, CER, CDP, PMS Plan, PSUR and both PMCF documents. €399 against €552 buying the eight separately.
Summary of Safety and Clinical Performance (SSCP) Template — EU MDR
One Word document, professional and lay content kept distinct.
€69.00
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