EU IVDR and MDR Compliance

A Scalable Solution to Meet the EU In vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR)

Problem:

  • Lack of Unique Device Identification (UDI) compliance is a significant threat to commercial operations
  • Product Labels must be revised to add the Device Identifier and other conforming changes
  • Expected exponential growth in Data Points from current and future UDI regulations
  • One Data Point = 1 Product Data Attribute for a single product packaging level
  • Example: each UDI country regulation expected to require 10-20 new data attributes 6 pending UDI initiatives + 28 EU countries yields between 350-700 new attributes for every product (current and future)

Solution:

Our turn-key solution provides UDI compliance that meets EU IVDR and MDR requirements, and provides flexibility and scalability to handle the UDI needs for tomorrow. Our team addresses all aspects of UDI, including labeling, direct marking, data attributes, transmission to the government databases, 3rd party supplier compliance, Implant Point of Use, Service and Repair items, and Accessories/Components to name just a few of the many areas involved. USDM retains the leading experts in UDI and brings decades of experience to your company, greatly accelerating the process while assuring compliance with all known requirements. We offer flexible delivery models that scale with your needs, from full management and resourcing of your UDI program to providing selected services from the areas outlined below.

Why does this matter? If your labels are not revised and/or accurate, data is not provided to governmental systems for UDI, your product is mis-branded and subject to regulatory action.

How do we do this? Our solution leverages our Single Source of Truth solution as a backbone, which contains a standard pre-configured set of data attributes needed to address internal operations, customer requirements, and global UDI requirements. Our experts are deeply involved with the evolution of the global regulations, and can quickly adapt the pre-configured solutions into your business. We are system-agnostic, and work within your current or planned framework to address these new needs.

One key focus area is the collection of the necessary attribute data to populate the data model. In our experience, up to 80% of the necessary data is not available in an electronic system or is not trustworthy, and must be manually captured, cleansed/enriched, reviewed, approved, and loaded. We are familiar with the processes needed to effectively capture and enrich necessary data and can significantly speed-up this activity. A key goal is to maximize data maintenance productivity to ensure the growth of resources is far below the growth of data points managed.

Pictorial Representation:

USDM UDI Solution

UDI Compliance

UDI Audits Single Source of Truth

Engaging with the industry-leading UDI experts at USDM provides you peace of mind that your UDI program will meet current and future requirements and assure compliance in the most efficient manner possible.

We bring the following key differentiators to every UDI engagement:

  • The most talented group of UDI experts available in the industry
  • Extensive experience working with over 50 current and former UDI clients
  • Every USDM client has met their required UDI requirements on-time
  • A set of pre-configured solutions covering processes/procedures, data models, and best-in-class software solutions, or we can use these tools to quickly update your existing processes and systems.

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials