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in saving lives by providing innovative healthcare solutions…DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...New RegulationsThe EU revised the laws governing medical devices and in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 announcement1 December 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representativesNews announcement29 November 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023News announcement20 October 2023Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lensesNews announcement18 October 2023MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components See all Highlights News 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 devicesNews announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for 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) Workshop07May2021Partner meetingsWebinar for Patients – Safe and performant Medical Devices for all 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 announcement1 December 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
News announcement29 November 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
News announcement20 October 2023Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
News announcement18 October 2023MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
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
News announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for 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
