OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. Latest updates News announcement20 March 2024Overview of language requirements for manufacturers of medical devicesNews announcement12 March 2024MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)News announcement22 February 2024Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devicesNews announcement6 February 2024MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024See all Highlights Study supporting the monitoring of availability of medical devices on the EU marketNews announcement5 August 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28Mar2023Conferences and summitsDay 2: 28 March 2023 IMDRF Stakeholder Forum27Mar2023Conferences and summitsDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop27-28Mar2023Conferences and summitsIMDRF 2023 23rd session 27-28 March 2023 - Brussels, Belgium Documents EventsPublications
OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…
DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...
New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.
News announcement12 March 2024MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
News announcement22 February 2024Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
News announcement6 February 2024MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany