Key Updates in Regulation (EU) 2024/1860: Implications for the Medical Device Industry
The new regulation brings significant changes that will impact both manufacturers and healthcare professionals. Here are the key highlights:
- Gradual Implementation of Eudamed: The Eudamed database, essential for transparency and traceability of medical devices, will be gradually implemented. This ensures an effective and efficient application of MDR and IVDR, allowing the use of individual electronic systems within Eudamed once their functionality is verified.
- Obligation to Inform about Supply Interruptions or Cessations: Manufacturers are now required to notify about any interruptions or cessations in the supply of medical devices. This measure is crucial to prevent shortages and ensure that patients and healthcare professionals have continuous access to necessary devices.
- Extension of Transitional Provisions for In Vitro Diagnostic Devices (IVD): The transitional periods for certain IVD devices have been extended, providing manufacturers with more time to comply with the new conformity assessment procedures. This extension is vital to avoid shortages of critical diagnostic devices and ensure their proper certification under the new regulations.
These modifications reflect the EU’s commitment to adapting to practical challenges in implementing the new regulatory framework, ensuring both patient safety and market stability.
📌 Stay informed and make sure your organization is aware of these changes to comply with the new regulatory obligations.
