OverviewThe EU has revised the legal framework of 3 directives to reflect progress over the last 20 years.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 announcement3 February 2026Medical Devices: Register now for high-level conference on 16 March 20261 min readNews announcement2 February 2026Registration - High-level Conference on Medical Devices: Innovation and Patient Safety - 16 March 2026, 9.00 - 17.00 CET1 min readNews announcement30 January 2026New publications of harmonised standards under the medical devices Regulations – January 20261 min readNews announcement16 December 2025New measures to make EU health sector more innovative, competitive and resilient1 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 read26 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 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 Events16Mar2026Conferences and summitsMedical Devices: Innovation and Patient Safety Brussels, Belgium04Jul2024Conferences 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 Forum DocumentsEventsPublications
OverviewThe EU has revised the legal framework of 3 directives to reflect progress over the last 20 years.
GuidanceThe European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are…
News announcement3 February 2026Medical Devices: Register now for high-level conference on 16 March 20261 min read
News announcement2 February 2026Registration - High-level Conference on Medical Devices: Innovation and Patient Safety - 16 March 2026, 9.00 - 17.00 CET1 min read
News announcement30 January 2026New publications of harmonised standards under the medical devices Regulations – January 20261 min read
News announcement16 December 2025New measures to make EU health sector more innovative, competitive and resilient1 min read
News announcement21 June 2022Setting the scene for EU reference labs for high-risk diagnostics1 min read
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 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
