Introducing Innovit’s EUDAMED Reference Center

Introducing Innovit’s EUDAMED Reference Center

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.   Even the most experienced companies uncover critical gaps in...

Introducing Innovit’s EUDAMED Reference Center

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.   Even the most experienced companies uncover critical gaps in...
EUDAMED: Regulation News and Updates

EUDAMED: Regulation News and Updates

The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020.  While the delay in EUDAMED certainly helps give us more time before we must submit information to the database...
URGENT: MDR Implementation – Postponed by EU Commission

URGENT: MDR Implementation – Postponed by EU Commission

The European Commission has announced a proposal to delay enforcement of the EU Medical Device Regulation by one year, from 26 May 2020 to 26 May 2021. The intent is to help relieve pressure from national competent authorities, notified bodies, industry and the...