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...
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 four technical amendments proposed last week by the...
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 catalog for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices (via...
Healthcare Providers and COVID-19: Flattening the Curve
On March 11, 2020, the World Health Organization designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continues to grow exponentially, social distancing has become the norm to slow the rate of transmission. The goal of...
Medical Device Manufacturing and COVID-19: Challenges & Opportunities
Medical Device manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic. Many are experiencing adverse impact to their supply chain and operations, financial expectations and emergency response plans. The need for...
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 & 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 give us more time before we must submit information to the database including...
MDR and Class I Medical Devices – What’s In, What’s Out?
European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED. Further, a grace period was also introduced by the EU for certain classes...
Is GHX Discontinuing Support for GUDID and EUDAMED?
In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market. As we ended 2019, several little birds have shared that GHX is slated to phase out support for their UDI Data Submission Service and will not be providing a...
Healthcare Insights – 2019 Recap
Happy New Year! As the dust settles from the holiday madness and end-of-year celebrations, we thought we’d take a quick look back and reflect upon our 2019 journey. We’re so fortunate to work with an amazing roster of customers and partners whose relationships are...