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IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By Elizabeth Orr

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

The word "Playbook" beside a checklist.
(iQoncept/Shutterstock)

A draft playbook from the International Medical Device Regulators Forum (IMDRF) lays out a six-step approach to developing new reliance initiatives, marking a more granular approach to international reliance projects.

The Playbook for Medical Device Regulatory Reliance Programs, published on 31 March, is open for comments...

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