OverviewThe EU has revised the legal framework of 3 directives to reflect progress over the last 20 years.Getting readyManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesGuidanceThe European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are… Latest updatesNews announcement28 March 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsNews announcement20 March 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 March 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews announcement10 February 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023See all HighlightsNews 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 announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 July 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDRThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events28Mar2023Conferences 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 DocumentsEventsPublications
OverviewThe EU has revised the legal framework of 3 directives to reflect progress over the last 20 years.
Getting readyManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
GuidanceThe European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are…
News announcement28 March 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods
News announcement20 March 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement7 March 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
News announcement10 February 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 July 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
