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in saving lives by providing innovative healthcare solutions…DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...New RegulationsThe EU revised the laws governing medical devices and in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. The… Latest updates News announcement6 December 2022Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745News announcement6 December 2022Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745News announcement6 December 2022MDCG 2022-17 - MDCG position paper on ‘hybrid audits’ - December 2022News announcement30 November 2022Updated information pack for candidate EU reference laboratories publishedSee 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 07May2021Partner 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DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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. The…
News announcement6 December 2022Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745
News announcement6 December 2022Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745
News announcement6 December 2022MDCG 2022-17 - MDCG position paper on ‘hybrid audits’ - December 2022
News announcement30 November 2022Updated information pack for candidate EU reference laboratories published
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
