EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860 Titelbild

EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860

EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860

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 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 extension? - What specific conditions must be met to keep your products on the EU market? - By when must you have a compliant Quality Management System in place? - What are the crucial deadlines for applying to and signing an agreement with a Notified Body? - What constitutes a 'significant change' that could void your eligibility? - How can you start preparing your application for a notified body right now? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. We act as your local representative in over 30 markets, develop efficient regulatory strategies, and use AI to compile technical dossiers. Our team helps you maintain compliance through post-market surveillance and continuous regulatory monitoring, ensuring your products meet international standards. Whether you're a startup or a multinational, we provide tailored solutions for your expansion needs. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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