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

May 29, 2020

Latest insights on FDA expectations from the 2020 Virtual HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS: FDA recognizes the constraints that COVID-19 has placed...

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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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May 6, 2020

Chinese government bodies introduce further COVID-19 responses

China’s NMPA, CMDE, and Ministry of Commerce have taken steps to balance supply needs with...

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Apr 29, 2020

COFEPRIS releases guidelines on priority devices amidst partial COVID-19 shutdown

Social distancing protocols caused most administrative activities to be suspended, but the government body is...

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COVID-19 resources

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