OverviewA number of Actors are relevant in the coordination and the governance of the medical devices sector.MDCG Working GroupsThe Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation…International CooperationPublic safety and healthcare are among the main responsibilities of all governments. Therefore, the European Commission started several policy and… Latest updatesNews 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 announcement24 May 2023Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/6071 min readNews announcement21 April 2023IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany1 min readNews announcement6 March 2023IMDRF – International Medical Device Regulators Forum 1 min readSee all HighlightsNews announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices1 min readNews announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices1 min read Events25-26Sep2023Conferences 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) Workshop27-28Mar2023Conferences and summitsIMDRF 2023 23rd session 27-28 March 2023 - Brussels, Belgium DocumentsEventsPublications
OverviewA number of Actors are relevant in the coordination and the governance of the medical devices sector.
MDCG Working GroupsThe Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation…
International CooperationPublic safety and healthcare are among the main responsibilities of all governments. Therefore, the European Commission started several policy and…
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 announcement24 May 2023Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/6071 min read
News announcement21 April 2023IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany1 min read
News announcement26 May 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices1 min read
News announcement24 May 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices1 min read
25-26Sep2023Conferences and summitsIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
