Post-market Clinical Follow-up

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Raisin picker

Raisin picker

Quite Involved in Discussions
#2
#2
According to MDR Annex III, a PMS plan contains
- a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
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A PMCF plan is always required. It might not be applicable for devices that have no direct influence on the patient, e.g. disinfectants. Or when the device is used in another device, e.g. dental implant colouring agents.
Always remember: PMCF ≥ PMCF study. You can often justify not to perform PMCF studies, but you can rarely justify not to perform any PMCF at all.
 
A

agrpyl

Registered
#3
#3
Raisin picker said:
According to MDR Annex III, a PMS plan contains

A PMCF plan is always required. It might not be applicable for devices that have no direct influence on the patient, e.g. disinfectants. Or when the device is used in another device, e.g. dental implant colouring agents.
Always remember: PMCF ≥ PMCF study. You can often justify not to perform PMCF studies, but you can rarely justify not to perform any PMCF at all.
Click to expand...
Thank You for your response. How can I justify not performing PMCF studies?
 
M

monoj mon

Trusted Information Resource
#4
#4
agrpyl said:
What are the scenarios when PMCF won't be required as per EU MDR?
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Have you checked previous discussions?

Raisin picker said:
A PMCF plan is always required.
Click to expand...
Plan: https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf
Report: https://ec.europa.eu/health/system/...20_8_guidance_pmcf_evaluation_report_en_0.pdf

agrpyl said:
How can I justify not performing PMCF studies
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DocsRoom - European Commission
 
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