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
Summary of Safety and Clinical Performance (SSCP) Template — EU MDR
What it is: a professionally drafted Word template for the SSCP required by Regulation (EU) 2017/745, Article 32 for Class III and implantable devices. The SSCP is intended for publication in Eudamed and addresses both healthcare professionals and patients.
What is included
- Professional and lay (patient) sections clearly distinguished
- Device identification and intended use
- Device description, accessories and combinations
- Residual risks, warnings and precautions
- Summary of clinical evaluation and PMCF outputs
- Intended clinical benefits
- Suggested profile for Eudamed publication
- References to MDCG 2019-9 Rev. 1
Format
1 Microsoft Word .docx file (fully editable) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full lifecycle?
This is 1 of 8 templates in the EU MDR Clinical Documentation Kit. Save 28% with the bundle: EUR 399 vs EUR 552 buying individually.
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.