IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany


The IMDRF was established in October 2011 and is a forum for medical device regulators from different jurisdictions who have agreed to work together to advance international regulatory harmonisation and convergence in the field of medical devices. The IMDRF builds on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) which was established in 1992 with the EU as one of the founding members.

The IMDRF Management Committee includes representatives from the EU (European Commission and representative EU Member States), Australia, Brazil, Canada, China, Japan, Singapore, South Korea and the USA. The World Health Organization (WHO) and Argentina are official observers to the IMDRF.

The IMDRF maintains working relationships with other international entities and regional organisations in order to foster global convergence. Through the leveraging of resources and expertise, we aim to promote high standards for safe and performant medical devices globally.

IMDRF produces guidance documents aiming at the facilitation of work of regulators and economic operators at global level.
Working Groups established by the Management Committee and operate under targeted mandates on specific activities identified in the IMDRF five-year strategic plan.
You can find the currently active working groups below.

Adverse Event Terminology
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
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Artificial Intelligence Medical Devices
Develop an aligned approach to the management of artificial intelligence based medical devices.
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Good Regulatory Review Practices
Develop good review practices for pre-market reviews and evaluations.
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Medical Device Cybersecurity Guide
Manage cybersecurity risks and medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.
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Personalized Medical Devices (PMD)
Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.
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Regulated Product Submission
Harmonize the format and content of regulatory submissions.
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Software as a Medical Device
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.
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