Guidance Clarifies EU Position On Alternatives To Notified Body On-Site Audits
Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.
You may also be interested in...
King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.
The European Commission has admitted that MDR implementation has been severely compromised by COVID-19, and potential delays in notified body conformity assessment of products must be addressed to avoid device shortages for patients.
Manufacturers That Are Nearly MDR-Ready May Lose Their Advantage Unless Audits Can Take Place Virtually
Industry is urgently seeking certainty over EU virtual notified body audits, fearing that companies now at the front of the MDR line might be sent to the back and have to reapply under the existing directives.