Changes to Approvals & Regulations of Medical Devices due to COVID-19

DUBLIN, July 10, 2020 /PRNewswire/ -- ResearchAndMarkets.com published a new article on the medical devices industry "Medical Devices and COVID-19 - Changes to the Approval Process"

Medical device manufacturers have concentrated their resources on devices to fight the COVID-19 pandemic. There has also been less demand for other medical devices due to a lower number of non COVID-19 related procedures being carried out. As a result some manufacturers have seen lower demand for their other medical devices and have temporarily closed production facilities and furloughed staff. Analysts expect that the impact of COVID-19 on the medical device industry could lead to greater demand for reshoring of device production and an increased focus on diagnostic devices. 

In order to avoid shortages of vital medical equipment, approval bodies in the US and European Union have granted priority review and delayed reporting requirements. In the US, the FDA has issued Emergency Use Authorizations for certain devices. The EUA designation provides expedited access to the US healthcare market but only lasts as long as the public health emergency for which they were granted. Similarly, the EU has postponed the Medical Device Regulation reporting deadline by one year. This regulation requires manufacturers to conduct post market studies to ensure the continued safety of their products.

To see the full article and a list of related reports on the market, visit "Medical Devices and COVID-19 - Changes to the Approval Process"

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