Greg Jacobson

In light of reports from healthcare professionals about the imminent risk of shortages of devices, Regulation (EU) 2023/607 was adopted by the EU authorities in view of the exceptional circumstances arising from an imminent risk of shortages of medical devices and the associated risk of a public health crisis. It became necessary to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and to extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market. This presentation covers the background that led to the current situation, eligibility- and key- requirements of the amending regulation, practical considerations on how to meet the May 26th 2024 deadline and potential impact to your business.

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