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

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 through 30 May. It was created by IMDRF’s Good Regulatory...

Key Takeaways
  • Comments on IMDRF’s draft Playbook for Medical Device Regulatory Reliance Programs are open through 30 May.
  • The document offers a step-by-step guide...

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