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PMCF Plan Template & Procedure

 PMCF (Post Market Clinical Follow Up) as per MDR article 83 is hard to understand, so preparation of fully complying PMCF procedures and templates is hard for newcomers as well those who has less time to spend in research.


As per MEDDEV 2.12-2 rev 2,and MDR Annex XIV Part B paragraph 6.2, each device PMCF study should have well defined PMCF plan describing the design and methodologies for proactive clinical data collection to ensure that safety, performance, user feedback, and clinical experiences. Its really hard for getting all the elements of the PMCF in right way, so use our ready and customizable PMCF Plan Procedure and templates. Our experts spend time and effort to develop procedures and template suitable for buyers to edit and use.


Interested parties can write to us or purchase directly from the I3CGLOBALwebsite.


Upon purchase, a download link will be manually sent to the email address provided. We’ll need anything from 1 to 5 hours.

Would you please if you do not receive a link within this time frame? We’ll see to it that you get it.

Post Market Clinical Follow Up (PMCF) Plan Procedure / SOP

PMCF Procedure : 200 USD

Procedure ID : I3C-PMCF-01/R2-10/19

Post Market Clinical Follow Up (PMCF) Forms / Templates

PMCF Device Selection : 50 USD

Template ID : I3C-TEM-22/R2-10/19

PMCF Plan : 300 USD

Template ID : I3C-TEM-23/R2-10/19

PMCF List of Study Centers : 50 USD

Template ID : I3C-TEM-24/R1-08/19

PMCF - Extended Follow Up of Clinical Investigation : 1000 USD

Template ID : I3C-TEM-25/R1-08/19

PMCF - New Clinical Investigation : 850 USD

Template ID : I3C-TEM-26/R1-08/19

PMCF - Device Registry Data : 850 USD

Template ID : I3C-TEM-27/R1-08/19

PMCF - Retrospective Study : 350 USD

Template ID : I3C-TEM-28/R2-10/19

Analysis & Conclusion : 350 USD

Template ID : I3C-TEM-29/R2-10/19

PMCF Evaluation Report : 350 USD

Template ID : I3C-TEM-30/R2-10/19

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