In vitro diagnostic medical devices Archives

Clinical trials, European Commission, European Union, In vitro diagnostic medical devices, Medical Devices

COMBINE programme launches a pilot coordinated assessment for clinical trials and performance studies

Last updated: 27 June 2025 To view updates, click on the ‘+’ sign below. What is COMBINE? COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research. When did the COMBINE Project 1 –…

27 June 2025

European Commission, In vitro diagnostic medical devices, Medical Devices

European Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

Last updated: 23 February 2024 See updated at the end of the post. On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an…

23 February 2024

European Commission, In vitro diagnostic medical devices, Medical Devices

Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs published

Last updated: 13 July 2024 To see updates, click on the ‘+’ sign below On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.…

11 July 2023

European Commission, In vitro diagnostic medical devices, mutual recognition agreement

Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs. Accordingly, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) are required to act in accordance…

2 June 2022