Getting readyInformation for actors active in the medical devices sector GuidanceThe European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are… Latest updatesNews announcement11 November 2024MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 20241 min readNews announcement26 July 2024Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Reg EU 2024/18601 min readNews announcement9 July 2024Information session on MDR/IVDR for international regulators – 4 July 20241 min readNews announcement22 February 2024Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices3 min readSee all HighlightsNews announcement5 August 2022Call for EU reference laboratories sent to Member States1 min readBenchmarks for high-risk diagnosticsNews announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics1 min readNews announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices1 min readGeneral 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 MDR1 min readThe 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 Events04Jul2024Conferences and summitsInformation session on MDR/IVDR for international regulators – 4 July 202425-26Sep2023Conferences 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) Workshop DocumentsEventsPublications
GuidanceThe European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are…
News announcement11 November 2024MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 20241 min read
News announcement26 July 2024Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Reg EU 2024/18601 min read
News announcement9 July 2024Information session on MDR/IVDR for international regulators – 4 July 20241 min read
News announcement22 February 2024Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices3 min read
News announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics1 min read
News announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices1 min read
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 MDR1 min read
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
04Jul2024Conferences and summitsInformation session on MDR/IVDR for international regulators – 4 July 2024
25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
