February 24, 2022 PMCF
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POST MARKET CLINICAL FOLLOW STUDIES (PMCF)_2021

The European Commission officially recognized nine harmonised standards for medical devices in commission implementing decision (EU) 2022/6 on January 4, 2022, which device manufacturers can use to meet the Medical Devices Regulation (MDR) conformity requirements.

Regions: The studies were performed worldwide covering Asia & Pacific, Europe, North, South/Latin America.

Number of Studies


Study type and design

In a total of 9912 subject population 24 were Interventional and 36 were Obsevational studies.

Details of Studies by Study Type and Design

Clinical Conditions being tested

In a total of 9912 subject population 24 were Interventional and 36 were Obsevational studies.

Details of Studies by Study Type and Design

Devices used in Intervention

Recruitment status

Length of follow-up for most studies was unavailable but for few PMCF studies was 1 month, 1.5 month, 1 year, 2 years, 5 years.

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