Introducing Innovit’s EUDAMED Reference Center by | | News

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.   Even the most experienced companies uncover critical gaps in their own internal systems and master data.   Under current timelines, a […]

Device Registration ‘is live’ for voluntary UDI data submission on EUDAMED by | | News

Last week, the European Commission announced the successful launch of its EUDAMED “Device Registration” and “NBs & Certificate” modules (Production release “v2.0 – September version” was deployed).  The EUDAMED UDI/Device Registration and NBs & Certificates modules have been successfully deployed into the Production environment and are available for use as of 4th October 2021.   You can find links to the EUDAMED restricted website and the public website below:  EUDAMED restricted  […]

FREE Early Access to the EUDAMED Test Environment! by | | News

Innovit is Excited to Announce Our EUDAMED.cloud Test Environment! To the best of our knowledge, we are the only company offering free access to a EUDAMED testing environment for all medical device manufacturers – helping you stay ahead of the curve for EUDAMED compliance. This new EUDAMED.cloud system is a cloud-based solution, serving as your […]

EUDAMED Implementation and Roll-Out Timeline Update by | | News

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 below:     Actor Registration Module – Already live. Device Registration (UDI) Module […]

An Important Milestone for the Medical Device Community: EU’s MDR-day has Arrived! by | | News

After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021 for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect. Yesterday, being the date of application of EU Medical Device Regulation (MDR) marks an important event for the medical devices market.

EUDAMED State of Play – New Playground Available for EUDAMED Device Registration and NBs & Certificates modules by | | News

What’s New? EUDAMED go-live date is still scheduled for May 2022.  But you may recall that in order to ensure a smooth and effective implementation, the EU Commission provides a “EUDAMED playground.”  It’s currently available for both manual web- based user access, and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies (NBs) […]

NEWS: EUDAMED State of Play: EU Commission delays EUDAMED Device Registration Go-live by | | News

The EU Commission provides a “EUDAMED playground” available for both manual web-based user access and automated M2M (machine to machine) Data Exchange for Actor Registration, Notified Bodies & Certificates, and Device Registration modules.  These testing “playgrounds” are available in different rounds and for specific time periods with test cases for each version. 

EUDAMED: Playground Testing Update by | | News

EUDAMED go-live date is still scheduled for May 2022.  In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies and Device Registration modules.  Three solution providers – including Innovit […]

PRESS RELEASE: B. Braun goes Live with Innovit direct GUDID connector by | | News

San Francisco, CA (September 23, 2020) Innovit, a global software company specializing in UDI compliance, Global Data Synchronization (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical Inc. (B. Braun) initiated its EUDAMED data submission project using Innovit’s UDI solution.  This comes after the team’s successful […]

FDA Delays UDI Deadline for Class I Devices to September 2022 by | | News

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 Class I devices by two years until Sep 24, 2022 due to COVID-19. In this guidance, the FDA […]

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