As a company, we didn’t do business with Group Purchasing Organizations (GPOs). Our strategy was to have a direct relationship with the customer. However, with UDI data, that changed.
Eudamed
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Innovit Client Completes M2M Tests with AusUDID and EUDAMED
Innovit is thrilled to announce that one of our customers, a global medical device company and leader in new product development and medical education in orthopedics, was the first to successfully complete M2M testing with AusUDID and one of the first to also successfully complete M2M EUDAMED testing.
Introducing Innovit’s EUDAMED Reference Center
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...
Gain market insight & a deeper understanding of EUDAMED requirements. Join the EUDAMED Leadership Council!
Innovit is excited to announce the formation of a EUDAMED Leadership Council Group on LinkedIn which includes participants from a number of leading medical device manufacturers including Arthrex, B. Braun, Bio-Rad, Medtronic, 3M,...
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...
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...
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...
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...
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-...
EUDAMED: Playground Testing Update
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...
EUDAMED and GUDID – What’s Changed?
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...
EUDAMED: Regulation News & Updates
The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. While the delay in EUDAMED certainly give us more time before we must submit information to the...
Is GHX Discontinuing Support for GUDID and EUDAMED?
In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market. As we ended 2019, several little birds have shared that GHX is slated to phase out support for their UDI Data Submission Service and will...
EUDAMED – Deadlines Updated
The European Commission recently announced that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for...
EUDAMED Go-Live is March 2020: Why waiting for more Technical Specifications is NOT a winning strategy
EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still...
Eudamed: Technical Specifications Update
Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed. As members of MedTech Europe and Healthcare...
Key Takeaways from the Europe Commission’s New EUDAMED Data Exchange Guidelines
As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed). Most recently, the European Commission (EC) released three...
EUDAMED & MDR: Readiness Tips
With a May 2021 go live date, The European Database for Medical Devices (EUDAMED) will be open to many more groups, including manufacturers, importers and sponsors. Current estimates are that this covers 70,000+ individual organizations and over...
Innovit, GS1 Global Healthcare Conference and new EUDAMED & MDR Challenges
We're attending the GS1 Global Healthcare Conference! Master data is at the center of important initiatives within healthcare including patient safety, post-market surveillance, supply chain optimization and regulatory compliance. While...