FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Updates Device Safety and Performance Assessment Guidelines

Jan. 30, 2018
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The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction.

The updated guidelines on the essential principles of safety and performance of medical devices and in vitro diagnostics seek to harmonize documentation and procedures to support global regulatory convergence.

IMDRF said the guidance provides benefits in establishing an economic and effective approach to the control of medical devices in the interest of public health, while at the same time striking a balance between the responsibilities of regulatory authorities to safeguard public health and their obligation to avoid placing unnecessary burden on manufacturers.

The guidance describes fundamental design and manufacturing requirements that should be considered throughout the lifecycle of medical devices and IVDs.  It lays out 14 essential principles that apply to all medical devices and IVDs, and it separates out additional principles that apply to each category.

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