ÜberblickMedizinprodukte und In-vitro-Diagnostika spielen eine wichtige Rolle bei der Rettung von Menschenleben, indem sie innovative Lösungen für Diagnose,…RichtlinienDerzeit gelten in der EU die nachstehenden Richtlinien über Medizinprodukte: Richtlinie 98/79/EG des Europäischen Parlaments und des Rates...Neue VerordnungenDie EU hat die Rechtsvorschriften über Medizinprodukte und In-vitro-Diagnostika bei der Überarbeitung an die Entwicklungen des Sektors in den letzten 20 Jahren angepasst. Latest updates News announcement1. Dezember 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representativesNews announcement29. November 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023News announcement20. Oktober 2023Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lensesNews announcement18. Oktober 2023MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components Alle anzeigen Highlights News announcement5. August 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 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 Events 25-26Sep2023Konferenzen und GipfeltreffenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28März2023Konferenzen und GipfeltreffenDay 2: 28 March 2023 IMDRF Stakeholder Forum27März2023Konferenzen und GipfeltreffenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07Mai2021Veranstaltungen mit PartnernWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
ÜberblickMedizinprodukte und In-vitro-Diagnostika spielen eine wichtige Rolle bei der Rettung von Menschenleben, indem sie innovative Lösungen für Diagnose,…
RichtlinienDerzeit gelten in der EU die nachstehenden Richtlinien über Medizinprodukte: Richtlinie 98/79/EG des Europäischen Parlaments und des Rates...
Neue VerordnungenDie EU hat die Rechtsvorschriften über Medizinprodukte und In-vitro-Diagnostika bei der Überarbeitung an die Entwicklungen des Sektors in den letzten 20 Jahren angepasst.
News announcement1. Dezember 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
News announcement29. November 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
News announcement20. Oktober 2023Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
News announcement18. Oktober 2023MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
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
25-26Sep2023Konferenzen und GipfeltreffenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
27März2023Konferenzen und GipfeltreffenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
07Mai2021Veranstaltungen mit PartnernWebinar for Patients – Safe and performant Medical Devices for all
