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Regulation (EU) 2024/1860 published on Official Journal of the European Union

By July 10, 2024No Comments

On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by:

  • Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31 December 2027, for class D devices; 31 December 2028, for class C devices; 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.
  • Enabling a gradual roll-out of EUDAMED- the new electronic database.
  • Requiring manufacturers to flag up potential shortages of critical medical devices and IVDs. This measure is crucial for maintaining a steady supply chain and ensuring patient safety.

This new regulation adopted will enter into force on the date of publication in the OJEU. Obligations regarding interruption or discontinuation of supply of devices shall apply from 10 January 2025.

The full legal text can be found here. If you have any questions on this regulation or how it might impact your organisation, please send these to Regulatory@bivda.org.uk.

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