Yleistä Lääkinnälliset laitteet ja in vitro ‑diagnostiikkaan tarkoitetut lääkinnälliset laitteet ovat elintärkeitä apuvälineitä. Ne tarjoavat… Direktiivit EU:ssa sovelletaan lääkinnällisiin laitteisiin toistaiseksi seuraavia direktiivejä: Euroopan parlamentin ja neuvoston direktiivi 98/79/EY Uudet asetukset EU tarkisti lääkinnällisiä laitteita ja in vitro -diagnostiikkaa koskevaa lainsäädäntöään, jotta se vastaisi alalla viimeisten 20 vuoden aikana tapahtunutta kehitystä. Ensisijaisena... Latest updates News announcement10 elokuu 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodiesNews announcement5 elokuu 2022Call for EU reference laboratories sent to Member StatesNews announcement13 heinäkuu 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)News announcement5 heinäkuu 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746Katso kaikki Highlights News announcement5 elokuu 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 kesäkuu 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 toukokuu 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 toukokuu 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 07tou2021 Kumppanikokoukset Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement10 elokuu 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
News announcement13 heinäkuu 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
News announcement5 heinäkuu 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 toukokuu 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 toukokuu 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
