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

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  […]

Webinar: Key Insights from Innovit’s Early EUDAMED Testing & Post Go-Live Feedback

The ever-changing EUDAMED compliance landscape has been flushed with uncertainty.  And, although the deadline delays may have come as a welcomed relief to some organizations, the mandate to comply is inevitable!   As one of the few vendors granted early access to the EUDAMED playground, Innovit has been afforded the opportunity to attend meetings, provide commentary, participate in […]

Tackling the Transition of GHX from UDI & EUDAMED Compliance — at the Same Time

GHX, a GDSN data pool and EDI solution provider, will phase out support for their GUDID Submission Service by December 2021, and do not have plans to provide a EUDAMED compliance solution.  If you’re a medical device labeler submitting device data to the GUDID via GHX and also have the requirement to submit data to EUDAMED by Q4 of 2022, then this development could seriously impact your UDI compliance initiatives.   As a workaround, some companies are building proprietary, in-house systems, while others are outsourcing the process to a data submission service provider using […]

FREE Early Access to the EUDAMED Test Environment!

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 […]

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

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 centers on the actual data submission – how to submit a large number of medical device records to EUDAMED in an efficient, scalable, and cost-effective process.  Today, there are really two main […]

EUDAMED Implementation and Roll-Out Timeline Update

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 […]

Global UDI Syndication Hub: Comparing Two Data Flow Models

First things first.  What exactly is a Data Flow Model? A data flow model is diagrammatic representation of the flow and exchange of data within a system. Data flow models are used to graphically represent the flow of data in an information system by describing the processes involved in transferring data from input processes to […]

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

Three Ways that Innovit is Leading the Charge in Healthcare Compliance

Today, medical device manufacturers are facing a wide array of data compliance demands from healthcare providers, and national regulators including the European Commission, FDA and China’s NMPA.  With the introduction of GUDID and now EUDAMED, these repositories capture important regulatory and clinical information about medical devices.  Of course, the primary goal of these various regulations […]

Country-Specific UDI Compliance – Staying Up to Date on Changing Deadlines

UDI Timeline: A progression of UDI compliance regulations and deadlines. One thing in healthcare is certain: patient safety and quality of care will continue to drive change in the healthcare market. UDI regulations support this objective and deadlines for implementation are looming. Every “labeler” of medical devices in America is required to maintain UDI data […]

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