Foundational Documents

Regulatory harmonisation is foundational to enabling medical device regulators worldwide to establish frameworks that are aligned and consistent. As a global leader in this domain, IMDRF plays a central role in developing and maintaining the documents that support these efforts.

Many of the core concepts regulators rely on today originate from the work of the Global Harmonization Task Force (GHTF). Since the transition to IMDRF, the regulatory landscape has continued to evolve, creating a need to ensure this body of work remains current and comprehensive.

The Foundational Documents Working Group aims to define a coherent set of core documents across existing GHTF and IMDRF materials, review relevant GHTF outputs for potential updating into IMDRF publications, and assess the overall completeness of this suite by identifying and addressing gaps in key concepts.

Through this work, the Working Group seeks to establish a comprehensive and up-to-date set of IMDRF documents that can serve as a practical reference for members and stakeholders in developing their regulatory frameworks, while supporting continued global harmonisation.