Rinvio per Eudamed (Banca dati europea dei dispositivi medici)

pubblicato il: 9 Dicembre 2019

Eudamed non partirà a maggio 2020, ma slitterà a maggio 2022. La notizia è apparsa  sul sito della Commissione Europea.

Resta ferma la data di applicazione del nuovo Regolamento (MDR) a maggio 2020   

EUROPEAN COMMISSION  –    INTERNAL MARKET, INDUSTRY, – ENTREPRENEURSHIP AND SMES

What is the state of play of the implementation of EUDAMED?

– The Commission is working on the implementation of the new EUDAMED database, which will improve transparency and coordination of information regarding medical devices available on the EU market.

– It will contain different modules on actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations and performance studies and market surveillance.

– The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.

– The date of application of the MDR remains May 2020.