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EUDAMED and GUDID – What’s Changed?

by Innovit Corporate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID

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

by Innovit Corporate Affairs | Sep 2, 2020 | Blog

  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...

FDA Delays UDI Deadline for Class I Devices to September 2022

by Innovit Corporate Affairs | Jul 7, 2020 | Blog, UDI

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...

PRESS RELEASE: Innovit and Atrify Renew Global Partnership

by Innovit Corporate Affairs | May 5, 2020 | News

SAN FRANCISCO – May 5, 2020 – PRLog — Innovit, a global software company specializing in UDI compliance (Unique Device Identification), GDSN (Global Data Synchronization), MDM (Master Data Management) and PIM (Product Information Management)...

EU-MDR Date of Application – Postponed…

by Innovit Corporate Affairs | Apr 22, 2020 | Blog, MDR

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 European Council, without additional...
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Recent Posts

  • Regulatory Update: Australia’s UDI Regulation Now in Effect
  • 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

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