FDA Delays UDI Deadline for Class I Devices to September 2022

FDA Delays UDI Deadline for Class I Devices to September 2022

The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices.  Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...

Innovit and atrify Renew Global Partnership

Global partnership will focus on providing customers with solutions to share reliable and proven product data with their business partners. SAN FRANCISCO – May 5, 2020 – PRLog — Innovit, a global software company specialising in UDI compliance...
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...