Category In vitro diagnostic 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…

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

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

Last updated: 7 December 2023 See updates at the end of the post. 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. This…

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

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…

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