Today, 30 May 2024, the Council formally adopted the new rules to amend the Medical Devices Regulations, the MDR and IVDR. The updates bring new measures for the transition period to the Regulations and for the shortages’ prevention.
The measures include:
- extending the transition period for certain IVDs
- enabling a gradual roll-out of EUDAMED
- requiring manufacturers to inform about potential shortages of critical medical devices and IVDs
Next step: OJEU publication
The Regulation is adopted today, 30 May, and will enter into force following publication in the Official Journal of the European Union.
The amendments have a significant impact on manufacturers of medical devices and IVDs. Do you have questions on how to place your medical devices and IVDs on the EU market? Submit your questions here.
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