Informacje ogólne Wyroby medyczne oraz wyroby medyczne do diagnostyki in vitro odgrywają podstawową rolę w ratowaniu życia, zapewniając innowacyjne rozwiązania w… Obecne dyrektywy Obecnie w UE obowiązują następujące dyrektywy w sprawie wyrobów medycznych: 1998 r. – dyrektywa 98/79/WE Parlamentu Europejskiego i Rady w sprawie… Nowe rozporządzenia Unia dokonała przeglądu przepisów dotyczących wyrobów medycznych i diagnostyki in vitro i dostosowała je do zmian, jakie nastąpiły w tym sektorze w ciągu ostatnich 20 lat. … Latest updates News announcement | 20 maj 2022MDCG 2022-9 - Summary of safety and performance templateNews announcement | 20 maj 2022MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022News announcement | 20 maj 2022MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746News announcement | 4 maj 2022MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDRZobacz wszystko Highlights General publications | 26 maj 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 activitiesCommission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devicesGeneral publications | 12 lipiec 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 czerwiec 2020List of COVID-19 essential Medical Devices (MDs and IVDs)General publications | 24 czerwiec 2020Guidance on regulatory requirements for medical face masksGeneral publications | 3 kwiecień 2020Guidance: Active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context Events 07MAJ2021 Spotkania partnerskie Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement | 20 maj 2022MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
News announcement | 20 maj 2022MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
News announcement | 4 maj 2022MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
General publications | 26 maj 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
Commission Implementing Regulation (EU) 2020/1207 on common specifications for the reprocessing of single-use devices
General publications | 12 lipiec 2020Commission guidelines on Union-wide derogations for medical devices
General publications | 3 kwiecień 2020Guidance: Active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
