Pregled Evropska komisija s širokim naborom oblik dialoga in sogovornikov podpira države EU, ki uvrščajo javno varnost in zdravstveno varstvo med svoje… Delovne skupine MDCG Koordinacijska skupina za medicinske pripomočke (MDCG) obravnava ključna vprašanja s področja medicinskih pripomočkov, kot so nadzor priglašenih… Mednarodno sodelovanje Javna varnost in zdravstveno varstvo sta med glavnimi odgovornostmi vseh vlad, zato je Evropska komisija začela več političnih in regulativnih… Latest updatesNews announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement13 april 2022Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devicesNews announcement7 februar 2022Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDRNews announcement4 oktober 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basisOglejte si vse HighlightsNews announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesNews announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices DocumentsPublications
News announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement13 april 2022Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices
News announcement7 februar 2022Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR
News announcement4 oktober 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
News announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
News announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices