The International Medical Device Regulators Forum (IMDRF) has published the Playbook for Medical Device Regulatory Reliance Programs It’s a comprehensive and practical guide designed to support regulatory authorities in developing, implementing, and strengthening reliance approaches that are efficient, transparent, and adaptable.
The IMDRF released Playbook for Medical Device Regulatory Reliance Programs, represents an important step forward in advancing regulatory convergence and international cooperation. It offers practical strategies and actionable considerations with the aim of streamlining regulatory processes access to safe and effective medical devices worldwide. It builds on established regulatory principles and provides a flexible framework that can be tailored to different jurisdictions and technologies across the medical device lifecycle.
Why regulatory reliance matters
Regulatory reliance is increasingly recognized as a key enabler of:
- More efficient use of regulatory resources
- Reduced duplication of assessments
- Greater predictability for manufacturers
- Enabling patient access to safe, effective, and high-quality medical devices
- Stronger global regulatory trust networks
By offering a practical roadmap for authorities at different stages of maturity, the IMDRF playbook supports the implementation of reliance models that are transparent, risk-based, and adaptable to national frameworks.
Importantly, the playbook does not prescribe a single model. Instead, it provides flexible approaches that can be tailored to jurisdictional needs, legal structures, and public health priorities.
BSI’s contribution and commitment
BSI is proud to have actively participated in the development and drafting of this Playbook, contributing technical expertise and practical insight drawn from extensive experience in conformity assessment, regulatory systems, and international collaboration.
Participation in this initiative reinforces BSI’s long-standing commitment to advancing regulatory science, strengthening international harmonization, and supporting robust yet efficient oversight frameworks.
As a Global Standards Body and conformity assessment organization working closely with regulators and industry worldwide, BSI recognizes the critical importance of collaboration in addressing evolving healthcare technologies and increasing system complexity. Contributing to this Playbook reflects BSI’s broader mission: building trust, improving patient safety, and enabling innovation through internationally aligned regulatory approaches.
We encourage stakeholders across the medical device ecosystem to review the playbook and consider how its principles may support their own regulatory strategies and collaborative initiatives.
