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.

Brazil Emergency Use Pathways for Medical Devices and IVDs

In case of emergency or pandemic situations, ANVISA has special registration routes, according to RDC 03/2010. In response to the COVID-19 outbreak, ANVISA published additional regulations RDC 346/2020, RDC 348/2020, and RDC 349/2020 for devices related to COVID-19 or SARS-CoV-2.

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

Get the latest medical device regulatory news on COVID-19. View All

Jul 7, 2020

European Commission publishes survey results on Notified Body COVID-19 capacity

Also released were a new list of medical devices and IVDs essential to combating the...

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Jul 1, 2020

TGA releases new fee schedule and announces reform delays

The impact of the COVID-19 pandemic can be seen in the postponement of the new...

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Jun 23, 2020

Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic

How can companies safely resume in-person usability research and testing during the coronavirus public health...

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May 27, 2020

US FDA to temporarily accept changes to devices approved through PMA or HDE

Normal requirements for regulatory submissions or notification periods will be waived in certain cases impacted...

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May 13, 2020

EFTA countries and Russia introduce COVID-19 policy changes

Outside the European Union, regulatory responses to the pandemic are emerging from Norway, Iceland, Switzerland,...

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COVID-19 resources

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