Periodic Safety Update Report (PSUR) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Periodic Safety Update Report (PSUR) Template — EU MDR
What it is: a professionally drafted Word template for the PSUR required by Regulation (EU) 2017/745, Article 86. The PSUR summarises the post-market data analysis and benefit-risk profile evolution over time.
What is included
- Executive Summary (status of previous actions, data collection period, benefit-risk conclusion)
- Devices covered and grouping justification
- Production volume, population analysis and usage frequency
- Status of actions from previous PSUR
- Risk-benefit analysis based on post-market data
- Serious incidents and FSCAs (Article 87), trend reporting (Article 88)
- References to MDCG 2022-21
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.