Accelerated market access for COVID-19 related devices

In response to the COVID-19 outbreak, many medical device market regulators are releasing Emergency Use Authorizations (EUAs) and expedited regulatory pathways for devices healthcare providers need most, including ventilators, face masks and PPE, and test kits, among others. Some authorities are reclassifying products to streamline market entry and avoid shortages. The situation is changing rapidly, and Emergo by UL is committed to monitoring these developments to deliver regulatory news and intelligence that helps medical device companies respond quickly to COVID-19. 

COVID-19 resources from Emergo

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Emergo consultants are monitoring emergency use developments in markets affected by COVID-19. View all markets >

Medical Device and IVD Emergency Use Routes in Europe

In response to the COVID-19 outbreak, the EC has temporarily allowed the marketing of non-CE marked personal respiratory protective equipment, certain medical devices and IVDs, and biocides.

US FDA Emergency Use Pathways for Medical Devices and IVDs

The US FDA has declared the COVID-19 outbreak to be a public health emergency and invoked their authorities for Emergency Use Authorization (EUA), through which the FDA Commissioner may allow unapproved medical devices to be used for emergency applications.

Mexico Emergency Use Pathways for Medical Devices and IVDs

In light of the current COVID-19 emergency, COFEPRIS has published two official communications (March 26 and April 17) regarding its policies during this time, stating that all administrative terms and deadlines are to be stopped between March 26 and April 30, in order to deploy resources to perform essential functions related to COVID-19.

Remote Usability Testing Helps Ensure Effective Medical Device Use

A number of rapid, remote assessments, such as optimizing user interface, creating instructions for use, and usability test, can be performed to help ensure products are used safely and effectively.

Australia Emergency Use Pathways for Medical Devices

In response to the COVID-19 outbreak, the TGA has emergency exemptions that allow for the importation and sale of some devices, including COVID-19 IVD test kits, and products without the normal registration requirements, or expedited registrations, where applicable.

Mitigating Cybersecurity Risks in Emergency Situations

Medical device companies working to address COVID-19 need to mitigate cybersecurity risks associated with managing the outbreak.

Blog

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May 11, 2021

US FDA and HHS withdraw proposed 510(k) exemptions for selected Class II medical devices

The government bodies identified flawed reasoning behind the January notice with the proposed exemptions, which...

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Apr 5, 2021

US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview

US FDA may be winding down Emergency Use Authorization (EUA) designations for medical devices and...

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Mar 30, 2021

US FDA to stop authorizing new imported respirators under reissued Emergency Use Authorization

The EUA, which covers non-NIOSH-approved disposable filtering facepiece respirators (FFRs) imported from countries other than...

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Mar 22, 2021

US FDA publishes EUA templates for COVID-19 IVD submissions

New and updated templates have been released to support Emergency Use Authorization (EUA) requests during...

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Mar 8, 2021

NMPA reports detail Chinese regulatory activities in 2020

Medical device and IVD registrations and new standards are summarized in the two reports, demonstrating...

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COVID-19 resources

Get the most recent content from our resource library on COVID-19. View All