Latest / Medical Device Global Market Access
EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860
This episode details the crucial extension of the In-Vitro Diagnostic Regulation (IVDR) transition periods under the EU's Regulation 2024/1860. We explore the specific, time-sensitive conditions manufacturers must meet to benefit from this extension, including Quality Management System requirements and mandatory engagement with a Notified Body. This is essential information for any IVD manufacturer looking to maintain market access in the European Union. - What is Regulation (EU) 2024/1860 and how does it affect your IVD products? - Are your legacy devices eligible for the new IVDR transition…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.