PMCF Plan Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
PMCF Plan Template — EU MDR
What it is: a professionally drafted Word template for the Post-Market Clinical Follow-up Plan required by Regulation (EU) 2017/745, Article 61(11) and Annex XIV Part B. The PMCF Plan defines the activities for proactive collection of clinical data on the marketed device.
What is included
- Specific objectives of the PMCF
- Methods justification per Annex XIV Part B
- Activity programme: literature monitoring, surveys, registries, RWD, PMCF clinical study
- Reference acceptance criteria
- Threshold triggers and action logic
- Roles and responsibilities, timeline and reporting frequency
- References to MDCG 2020-7
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.