Prehľad Zdravotnícke pomôcky a diagnostické zdravotnícke pomôcky in vitro zohrávajú zásadnú úlohu pri záchrane životov tým, že poskytujú inovačné riešenia v… Súčasné smernice V súčasnosti sa v rámci EÚ uplatňujú tieto smernice o zdravotníckych pomôckach:1998: Smernica 98/79/ES Európskeho parlamentu a Rady o diagnostických… Nové nariadenia EÚ zrevidovala právne predpisy upravujúce zdravotnícke pomôcky a diagnostiku in vitro tak, aby bola v súlade s vývojom v tomto odvetví za posledných 20 rokov. EÚ… Latest updates News announcement | 25 máj 2022Public health: Stronger rules for placing medical tests on the marketNews announcement | 25 máj 2022MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746News announcement | 24 máj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement | 20 máj 2022MDCG 2022-9 - Summary of safety and performance templateZobraziť všetky Highlights News announcement | 24 máj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement | 26 máj 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 júl 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 jún 2020List of COVID-19 essential Medical Devices (MDs and IVDs)General publications | 24 jún 2020Guidance on regulatory requirements for medical face masks Events 07máj2021 Stretnutia partnerských subjektov Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement | 25 máj 2022MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
News announcement | 24 máj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement | 24 máj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement | 26 máj 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 júl 2020Commission guidelines on Union-wide derogations for medical devices
07máj2021 Stretnutia partnerských subjektov Webinar for Patients – Safe and performant Medical Devices for all