Live! #2 — Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency
Manage episode 263164074 series 2688337
This is the audio-only version of DEVICE LOVE Live! #2, originally recorded April 24th, 2020.
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:
- The overall process and requirements
- What products this regulatory route can be used for
- Explain the “shortcuts” this provides
- What these processes are NOT intended for
- And more!
Does your organization have a product that could utilize these pathways? Do you have questions on how to get this done quickly and effectively?
- Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
- Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
- Niki Spaniel — Senior Principal Specialist, R&Q
- Kevin Go — Senior Engineer, R&Q (former FDA)
- Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
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