The International Medical Device Regulators Forum (IMDRF) made further progress towards global harmonization of device standards at its most recent meeting, held for the first time as a virtual conference due to COVID-19 restrictions.
Among other actions at the September meeting, hosted by Singapore, IMDRF approved the final draft of a document on conformity assessment bodies that conduct medical device regulatory reviews.
The IMDRF management committee also approved a separate document on training requirements for regulatory authority assessors of conformity assessment bodies conducting medical device regulatory reviews.
In addition, the committee approved proposed documents on expanding the harmonization of adverse event terminology and considerations for validating designs and personalized medical device production systems.
The presentations and documents made available at the meeting can be accessed from here.