Medical device makers should report all adverse events in pre-market clinical trials, including serious health threats, unanticipated serious effects, as well as any deficiencies that might lead to a serious adverse event, states the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.
A partnership between regulatory authorities and regulated industry, the GHTF is comprised of members from the U.S., the European Union, Canada, Australia, and Japan.
The document represents a global model providing guidance on the types of adverse effects and events associated with clinical investigations of devices that should be reported by sponsors. It outlines the scope of reportable events, definitions, a timeline of when they must be reported, and to whom.
It aims to set out a uniform system of reporting globally and is applicable to pre-market clinical investigations to obtain regulatory approval for placing the device on the market and/or premarket investigations that require authorization by the relevant regulatory authority prior to initiation.
This guidance is also supported by the requirements of the International Organization for Standardization’s guideline on Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practices.
