In this free webinar, the featured speakers will discuss the impact of COVID-19 on the medical device regulatory and clinical landscape including Notified Bodies (NBs) and the one-year delay of MDR, site audits and associated changes within the EU. They will give a recap of changes to Quality Systems such as the impacts to third party internal audits and supplier audits. Attendees will learn about considerations for EU and US clinical studies.
TORONTO (PRWEB) June 03, 2020
Due to COVID-19, regulatory agencies are relaxing guidelines and shifting priorities to address shortages in diagnostics and respiratory devices. The current pandemic led to the one-year delay of the new European Union (EU) Medical Device Regulation (MDR), allowing authorities and manufacturers to continue under current procedures. This delay also provides more time for the European Commission to issue guidance documents. Despite this deadline extension, manufacturers should where possible continue with current plans to certify devices under MDR, as Notified Bodies (NB) are continuing to be designated under MDR.
During uncertain times, it is necessary to understand current regulations and what it means for your development programme.
In this webinar, our regulatory and clinical experts will discuss the new challenges arising from the COVID-19 crisis and how to best navigate the regulatory landscape moving forward.
- Impact on Notified Bodies (NBs) including the one-year delay of MDR, site audits and associated changes within the EU (UK & Brexit, Switzerland, Turkey)
- Recap of changes to Quality Systems such as the impacts to third party internal audits and supplier audits
- Considerations for EU and US clinical studies including: CE marking versus US approval processes, emergency use authorization, flexibility in timing and sterilization concerns
Join Sarah Sorrel, President and CEO, MedPass International, an ICON plc company, David Francis, Director of Strategic Consulting, MedPass International, an ICON plc company and Angela Brown, BS, Director, Regulatory Affairs, ICON plc in a live webinar on Thursday, June 11, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Navigating the “New Normal” During COVID-19: A Regulatory and Clinical Perspective for medical devices.
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For the original version on PRWeb visit: https://www.prweb.com/releases/navigating_the_new_normal_during_covid_19_a_regulatory_and_clinical_perspective_for_medical_devices_upcoming_webinar_hosted_by_xtalks/prweb17164365.htm