FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Posts Three Final Guidances

Nov. 21, 2018
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The International Medical Device Regulators Forum (IMDRF) released final guidances on optimizing standards for regulatory use, essential principles of safety and performance, and definitions for personalized devices.

Following up on the forum’s Sept. 18-20 meeting in Beijing, the Standards Working Group issued guidance on optimizing standards for regulatory use, noting that optimizing standards will help to streamline regulatory processes as medical devices grow in complexity and international markets expand.

Most IMDRF regions have developed programs for consensus standards, and they have more in common than differences, which sets the stage for future harmonization, the working group said.

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