PMCF Evaluation Report Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
PMCF Evaluation Report Template — EU MDR
What it is: a professionally drafted Word template for the PMCF Evaluation Report per Regulation (EU) 2017/745, Annex XIV Part B. The PMCF Evaluation Report documents the outcomes of the activities defined in the PMCF Plan.
What is included
- Executive Summary (activities executed, key findings, impact on benefit-risk, actions triggered)
- Activities executed vs planned
- Results by activity (literature, vigilance, complaints, FSCAs, PMCF study, surveys, registries, RWD)
- Integrated analysis vs acceptance thresholds
- Update to state of the art
- Impact on the benefit-risk ratio and on the CER
- References to MDCG 2020-8
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
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.