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FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

by Innovit Corporate Affairs | Jul 29, 2022 | Blog, Michelle Laurion

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...
FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

Q&A: Is GDSN a Viable Option to Submit Data to EUDAMED?

by Innovit Corporate Affairs | Sep 4, 2021 | Blog

EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task.   Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due.  A large component of that strategy centres...
EUDAMED Implementation and Roll-Out Timeline Update

EUDAMED Implementation and Roll-Out Timeline Update

by Innovit Corporate Affairs | Sep 4, 2021 | Blog, Eudamed

The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...
Talking Brexit at the GS1 UK Healthcare Conference, London UK, 09-10 April 2019

Talking Brexit at the GS1 UK Healthcare Conference, London UK, 09-10 April 2019

by Innovit Product Team | Apr 2, 2019 | Blog, GS1

All eyes are on the U.K. this week as they continue navigating missed deadlines surrounding Brexit.  The news isn’t reassuring as reports indicate that business sentiment is on the decline as Brexit uncertainty continues.   Yesterday, it was announced that the...
The Importance of Healthcare Data Management

The Importance of Healthcare Data Management

by Innovit Corporate Affairs | May 28, 2018 | Blog, MDM

Healthcare data management is an essential part of working in the industry. You’re not only legally obligated to manage patient healthcare. Patients’ health outcomes often depend on your ability translate, store, and transmit records properly. Managing...

Recent Posts

  • EUDAMED Go-Live Announcement: Streamlined UDI Data Submission using Innovit EUDAMED Connector
  • Updated Timeline: Mandatory Use by Q4 2025 – Current planning for gradual roll out and modules’ functionality view
  • MDR Third Amendment is official: EUDAMED Mandatory Use by January 2026
  • TGA’s Australian UDI Database: Deadline Update

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