IMDRF Advances Key Device Documents at Virtual Meeting

The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic.

Among other actions at the Sept. 21-25 web conference hosted by Singapore, the forum 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.