International Medical Device Regulators Forum (IMDRF)

We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety.

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The impact of COVID-19

The International Medical Device Regulators Forum (IMDRF) acknowledges the significant impact that COVID-19 continues to have on all countries and citizens. The use of essential medical devices such as ventilators, oxygen concentrators, syringes and test kits have contributed to the efforts of pandemic responses around the world, as have other products regulated in some countries such as surgical face masks.

The IMDRF held a Joint Workshop on COVID-19 in March 2021, where members shared their experiences and challenges during the pandemic. Some of these included emergency use or other systems to expedite access and supply of essential medical devices, flexible and pragmatic approaches to regulatory processes such as remote inspections, and publishing information about approval pathways and availability of critical medical devices.

A link to each member country's website is below, where you can find more detailed information.

Working groups

Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.

Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.

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.