MDR Annex XIV Clinical Evaluation & PMCF Plan Form
Document your clinical evaluation and PMCF plan for a medical device submission using this structured planning form.
Device and Submission Details
Medical Device Name / Model
*
Device Class
*
Please Select
Class I
Class IIa
Class IIb
Class III
Manufacturer Name
*
Intended Submission Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Clinical Evaluation Planning
Purpose of Clinical Evaluation
*
Summary of Intended Clinical Claims or Intended Purpose
*
Key Clinical Data Sources to Be Reviewed
*
Clinical Evaluation Status / Stage
*
Please Select
Planning
In Progress
Draft Review
Final Review
Completed
Other
PMCF Plan and Follow-up
PMCF objectives
*
Follow-up activities and methods
*
Planned timing / frequency
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Responsible team / role
*
Submit Form
Should be Empty: