Amendments to MDR 2017/745 and IVDR 2017/746 Finally Published in the Official Journal

Regulation (EU) 2024/1860 (2024/0021/COD) was published in the Official Journal of the European Union (OJ) on 9 July 2024 making the latest amendments to the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) official. These amendments were originally proposed in January as COM(2024)43 and were later agreed to without changes by both the Council and European Parliament.

The original Commission proposal sought to address three key stakeholder concerns:
  1. Continued device availability especially for high-risk class D IVDs
  2. Continuity of supply of devices
  3. Improved traceability
The published amendments to the regulations address these concerns by incorporating:
  • Extensions to the deadlines by which various classes of legacy IVD devices must be no longer made available on the Union market and updates to the transitional provision for such devices;
  • Obligations on manufacturers to provide advanced notification of withdrawal of certain devices to Competent Authorities (CAs), health institutions (HIs), and healthcare professionals (HCPs) who are supplied these directly; and
  • A gradual implementation of EUDAMED by module.

Figure 1 provides an overview of the new IVDR transitional arrangements.