UDI Submission for China NMPA
Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market. It is a potential high-growth area for many global medical device manufacturers. So, if you’re a medical device...
EUDAMED and GUDID – What’s Changed?
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
Making Decisions in a COVID-19 World: Why Trusted Data Matters
Mistake by Florida on child COVID-19 rate raises the question: Can Florida's numbers be trusted? “It’s unacceptable to publish information that changes so dramatically that it warrants explanation, and then to not provide any explanation,” said Jason...
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...