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 announcement2 December 2024MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)1 min readNews announcement26 November 2024MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)1 min readNews announcement21 November 2024Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)1 min readNews 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 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 announcement2 December 2024MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)1 min read
News announcement26 November 2024MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)1 min read
News announcement21 November 2024Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)1 min read
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 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
