Extending Transition Periods for Critical IVDs
In a move addressing urgent concerns, the European Commission has put forth a proposal on January 23 to extend transition periods for specific In Vitro Diagnostics (IVDs). The focus is on mitigating the risk of shortages, particularly for high-risk IVDs crucial in scenarios such as blood and organ donation testing and blood grouping for transfusions.
Gradual Roll-out of Eudamed Electronic Systems
The proposal also outlines a strategic approach to the implementation of electronic systems integrated into the European database on medical devices, known as ‘Eudamed.’ Rather than deferring the mandatory use of Eudamed until the completion of all six modules, the proposal advocates for an incremental roll-out. This shift aims to enhance transparency by providing comprehensive information on devices in the EU market, facilitating improved monitoring of device availability.
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Prior Notice for Device Supply Interruptions
A notable inclusion in the proposal is a requirement for manufacturers to provide prior notice before interrupting the supply of certain critical medical devices and IVDs. This proactive measure aims to enhance preparedness and response mechanisms, ensuring a more resilient and stable supply chain.
Stay informed as we delve into the intricacies of these proposed amendments, providing insights into the evolving landscape of IVD regulations in Europe. For expert guidance on navigating regulatory changes, connect with operon strategist to ensure compliance and success in the dynamic field of medical devices.
