Potential Liability Issues With Emergency Use Ventilators In UK: A Lawyer’s Viewpoint
Having non-medtech manufacturers develop and deliver ventilators for use on COVID-19 patients has alarmed many regulatory experts in the medtech industry. What are the potential liability issues and under what conditions can these new products remain on the market? Sarah Cowlishaw and Grant Castle of law firm Covington & Burling give their views.
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Medtech regulatory parameters could be shifting as the UK makes an unprecedented call for other industries to produce ventilators to deal with the current COVID-19 situation.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?