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.
