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EUDAMED Timeline: Mandatory Use by Q4 2025

EUDAMED Timeline: Mandatory Use by Q4 2025

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.

TGA’s Australian UDI Database: Deadline Update

TGA’s Australian UDI Database: Deadline Update

Australia's healthcare landscape is on the brink of a transformative change with the imminent launch of the Australian Unique Device Identification (AusUDID) database by the Therapeutic Goods Administration (TGA). With the AusUDID set to go-live in...

Providing UDI data to Hospitals & GPOs Part 2

Providing UDI data to Hospitals & GPOs Part 2

Shortly after the FDA published the deadline for submitting UDI product information for Class II devices, I received an email from one of our sales representatives asking for help in submitting UDI data to one of our clients, a healthcare network consisting of several hospitals, medical centers, clinics, and a university health center.

Providing UDI data to Hospitals & GPOs Part 1

Providing UDI data to Hospitals & GPOs Part 1

As with most medical device companies, our journey into the world of UDI began with the introduction of new FDA requirements to publish product data with a unique number assigned to the product, such as a Global Trade Item Number (GTIN), in the FDA database.

Innovit Client Completes M2M Tests with AusUDID and EUDAMED

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.

The 12 Most Important Steps to Global UDI Compliance

The 12 Most Important Steps to Global UDI Compliance

The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023  The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people's health: Things like...

Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)

Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)

Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance. 

FDA Class I GUDID Compliance Regulation FAQ’s

FDA Class I GUDID Compliance Regulation FAQ’s

Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance. 

9-Steps to GUDID Class I Medical Device Compliance

9-Steps to GUDID Class I Medical Device Compliance

Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.

FAQ: Global Unique Device Identification Database (GUDID)

What is GUDID? GUDID is an acronym for the Global Unique Device Identification Database — a central repository of detailed medical device information created by the US FDA.  It is often pronounced “Good ID”.  The GUDID system was implemented as a...

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...

Innovit’s 2021 Recap and a Look Ahead!

2022 is almost here and the holiday season is in full flight!   As another turbulent year comes to an end, the team at Innovit took a moment to reflect on the past year while also looking ahead with zeal and optimism.  Though agility and...

Introducing MDM.Cloud

We’re excited to introduce you to Innovit’s next-generation solution, MDM.cloud for the Australian market! Current iICE Validator customers can take advantage of our MDM.cloud system upgrade NOW! MDM.cloud for NPC was initially created for...

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

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...

EUDAMED Implementation and Roll-Out Timeline Update

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...

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...

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

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: 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...

How Does the GDSN Work?

How Does the GDSN Work?

Globally, the medical device manufacturing sector continues to grow steadily due to aging populations in developed economies, growing health concerns and the acceleration of digital health.  But like any industry, growth requires the ability to...

GUDID Data Submission Services: 3 Potential Risks

As a medical device manufacturer, you are required to submit product data to the GUDID in order meet UDI compliance requirements.  If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets...

UDI Submission for China NMPA

Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market.  It is a potential high-growth area for many global medical device manufacturers.  So, if you’re a...

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...

EU-MDR Date of Application – Postponed…

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...