EU-MDR Date of Application – Postponed…

EU-MDR Date of Application – Postponed…

The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the 4 technical amendments proposed last week by the European Council, without bringing additional...
GUDID and UDI – Are You Prepared?

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalogue for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices...
Healthcare Providers and COVID-19: Flattening the Curve

Healthcare Providers and COVID-19: Flattening the Curve

On March 11, 2020, the World Health Organisation designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continue to grow exponentially, social distancing has become the norm to slow the rate of transmission. The goal, of...
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...
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...