Med Device Link Newsletter - July

Hello!

The start of summer brings a new FDA quality campaign and some updates on global health authority progress. See recent details below. We continue to monitor UDI activity and will keep you in the know as new information becomes available.

As always, we are here to help you monitor developments with UDI requirements.?Don't hesitate to reach out to us via email at:?[email protected]?if we can assist with updating GUDID records or preparing for other global health authority UDI submissions.?

Webinar Recordings

Ask the Experts:?Basic UDI-DI

Gary Saner and?Ronald Boumans?answer questions and provide scenarios regarding Basic?UDI-DI for EU EUDAMED.?View Recording

Ask the Experts: What Should I know about the EU Legacy Device Amendment?

In recent news, the European Commission enacted an extension to the transition deadline for Legacy Medical Devices to be placed on the EU market. This extension impacted multiple timelines, as well as specific requirements along the EUDAMED roadmap. View Recording

Upcoming Wednesday Webinar

UDI and Global MedTech Compliance Strategy

Gain immeasurable insights from REGDESK CEO,?Priya Paul (Bhutani), and industry expert?Gary Saner, Sr. Mgr. Information Solutions at?LexisNexis Reed Tech on navigating regulatory requirements to meet UDI compliance deadlines. Register Now

FDA Quality Campaigns

The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID). As a medical device manufacturer or other organization responsible for reporting medical device UDI information to the GUDID, i.e., a Labeler, you may be affected by these initiatives and need to react promptly.

Learn More

Did you get a FDA Letter about 'Missing Devices' in GUDID?

A?quick video update?on the recent FDA quality campaign concerning product data. If you have products missing in GUDID, we can help. Email us:?[email protected].

Introducing the 'Understanding UDI Series'

Access the?'Understanding UDI Series'?for short tutorials and quick reference slides. Learn more about regulations, requirements and timelines for Global Health Authorities. See how you score on the quiz!?Unlock the Series

Questions? Ask the Experts

If your team has questions about health authority requirements, device classes, Unique Device Identification (UDI) data attributes, or related topics, get in touch! We'd be happy to help. [email protected]