OverzichtDe EU heeft het huidige wetgevingskader (drie richtlijnen) aangepast aan de vooruitgang van de afgelopen 20 jaar.VoorbereidingManufacturer IVDAuthorised Representatives, Importers and DistributorsRichtsnoerenDe Europese Commissie heeft diverse richtsnoeren opgesteld om de betrokkenen te helpen bij de uitvoering van de verordeningen voor medische… Latest updatesNews announcement31 augustus 2023MDR and IVDR Communication SurveyNews announcement17 juli 2023Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devicesNews announcement30 juni 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateNews announcement21 juni 2023New Commission Implementing Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose (Annex XVI)Zie alle HighlightsNews announcement5 augustus 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 juni 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 mei 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 juli 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 Events25-26sept.2023Conferenties en topontmoetingenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mrt2023Conferenties en topontmoetingenDay 2: 28 March 2023 IMDRF Stakeholder Forum27mrt2023Conferenties en topontmoetingenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07mei2021Vergaderingen met partnersWebinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
OverzichtDe EU heeft het huidige wetgevingskader (drie richtlijnen) aangepast aan de vooruitgang van de afgelopen 20 jaar.
RichtsnoerenDe Europese Commissie heeft diverse richtsnoeren opgesteld om de betrokkenen te helpen bij de uitvoering van de verordeningen voor medische…
News announcement17 juli 2023Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
News announcement30 juni 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
News announcement21 juni 2023New Commission Implementing Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose (Annex XVI)
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 mei 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 juli 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
25-26sept.2023Conferenties en topontmoetingenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
27mrt2023Conferenties en topontmoetingenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
07mei2021Vergaderingen met partnersWebinar for Patients – Safe and performant Medical Devices for all
