The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its guidance document on post-marked clinical follow-up (PMCF) studies for medical devices.
According to a posting last month to the website of the Regulatory Affairs Professionals Society (RAPS), the update outlines the general principles that should inform PMCF studies for medical devices, when a PMCF study is indicated, the design and implementation of such studies, and the use of clinical information resulting from the study. The update does not apply to in vitro diagnostic devices.
The IMDRF is a forum of medical device regulators from around the world focused on the harmonization of international medical device regulations. Current members of the IMDRF include the U.S., the European Union (EU), China, Japan, Australia, Brazil and Canada.
The proposed update, issued by the IMDRF’s Medical Devices Clinical Evaluation Working Group, is reportedly open for consultation until mid-November.