Overzicht De EU heeft het huidige wetgevingskader (drie richtlijnen) aangepast aan de vooruitgang van de afgelopen 20 jaar. VoorbereidingManufacturer IVDManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesRichtsnoeren De Europese Commissie heeft diverse richtsnoeren opgesteld om de betrokkenen te helpen bij de uitvoering van de verordeningen voor medische… Latest updatesNews announcement5 augustus 2022Call for EU reference laboratories sent to Member StatesNews announcement5 juli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746News announcement21 juni 2022Setting the scene for EU reference labs for high-risk diagnosticsNews announcement24 mei 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesZie 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 Events07mei2021 Vergaderingen met partners Webinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
News announcement5 juli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
News announcement24 mei 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
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
07mei2021 Vergaderingen met partners Webinar for Patients – Safe and performant Medical Devices for all
