Category 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

Medical Device Coordination Group updates: October – December 2023

Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…

Read MoreMedical Device Coordination Group updates: October – December 2023

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