Vue d’ensembleLes dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro jouent un rôle sanitaire essentiel en offrant des solutions innovantes…Directives en vigueurLes directives relatives aux dispositifs médicaux suivantes s'appliquent actuellement dans l’UE:1998: Directive 98/79/CE du Parlement européen et du…Nouveaux règlementsL’UE a révisé la législation régissant les dispositifs médicaux et les diagnostics in vitro afin de l’aligner sur l’évolution du secteur survenue au cours des 20 dernières années. L'UE… Actualité News announcement14 septembre 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)News announcement14 septembre 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)News announcement26 août 2022MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsNews announcement10 août 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodiesTout afficher À la une News announcement5 août 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 juin 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 announcement24 mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 mai 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Evénements 07mai2021 Réunions de partenaires Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
Vue d’ensembleLes dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro jouent un rôle sanitaire essentiel en offrant des solutions innovantes…
Directives en vigueurLes directives relatives aux dispositifs médicaux suivantes s'appliquent actuellement dans l’UE:1998: Directive 98/79/CE du Parlement européen et du…
Nouveaux règlementsL’UE a révisé la législation régissant les dispositifs médicaux et les diagnostics in vitro afin de l’aligner sur l’évolution du secteur survenue au cours des 20 dernières années. L'UE…
News announcement14 septembre 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)
News announcement14 septembre 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)
News announcement26 août 2022MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs
News announcement10 août 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 mai 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 mai 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
