The European Union adopted Regulation (EU) 2023/607 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 transition period during which those devices that are in conformity with those Directives can continue to be lawfully placed on the market. This presentation covers the background that led to the current situation, eligibility- and key- requirements of the amending regulation.
The objectives of this webinar are:
Target Audience: This webinar is aimed at regulatory professionals of legal manufacturers of medical devices who intend to continue placing products on the EU market until the end of the transition on December 31, 2028.
Cost: No Charge
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