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 methods for submitting data via M2M to regulatory agencies – […]
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 […]
EUDAMED State of Play – New Playground Available for EUDAMED Device Registration and NBs & Certificates modules
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) […]
Innovit Q&A: M2M Testing – What it means and why it’s important.
Medical Device Regulation (MDR) are a set of recent European regulations aimed to enhance patient safety and modernize public health. Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical Device Directives) first established in 1992. Key elements of the new MDR include the expansion […]