Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency
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In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply. However,some manufactures lack the necessary regulatory approvals needed to make their medical devices/PPE available. In situations such as these, both the United States (FDA) and European Union (European Commission) have legislation in place to help bring these critical products to patients and healthcare workers for emergency applications.
In the United States, the US FDA has invoked the Emergency Use Authorization (EUA) authorizing the use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met.
In the European Union, Article 59 of the EU MDR (2017/745) can be used where the European Commission is responsible for identifying and authorizing certain medical devices and PPE that may be sold without CE Marking during the public health emergency and market access is granted individually by the Competent Authority of each member state. The EU has already issued an implementing act restricting export of PPE from the EU and recommended conformity assessment procedures within the context of COVID-19 threat, including extraordinary measures related to notified body audits.
In this show, we’ll discuss both emergency applications and talk with experts on:
Does your organization have a product that could utilize these pathways? Do you have questions on how to get this done quickly and effectively? Please join us and bring your questions to learn more.
Please come with questions!