CORIDIAN Technologies, Inc. 1725 Lake Drive West, Chanhassen, MN 55317 (952) 361-9980 CORIDIAN.com

UDI Solutions

Per the Food and Drug Administration (FDA) and the European Union (EU) standards, the intention of Unique Device Identi�cation (UDI) is to improve patient safety and device traceability. All medical device manufacturers who wish to continue selling their products in the United States (US) or the EU must become UDI compliant. Becoming UDI compliant involves two requirements:

1. All medical devices must have a UDI compliant barcode on the label that contains a Device Identi�er (DI) and Product Identi�er (PI), along with other label symbols that correspond to the device and its packaging properties.

2. All device manufacturers are responsible for gathering and uploading upwards of 60 device data attributes to governmental regulatory databases. The US database is the Global Unique Device Identi�cation Database (GUDID) and the EU database is the European Databank on Medical Devices (EUDAMED). All data changes going forward must be updated in GUDID and EUDAMED and recorded internally as part of the manufacturers documented Quality Management System (QMS).

What is UDI and Why Do You Need to Comply?

The Business Challenge

UDI is Here Now - Deadline for Class I devices in the US is September 24, 2020. New EU standards, Medical Device Regulations (MDR), take e�ect on May 25, 2020. From these dates forward, device data and labeling will need to meet UDI standards.

Start Now - FDA statistics for US UDI show average implementation time of 6-12 months, while early EU MDR estimates double that time frame.

No Grandfathering of Existing Device Certi�cates - Once the MDR goes into e�ect in May 2020, even existing products soldunder an active Medical Device Directives (MDD) certi�cate will need to provide MDR level data immediately in the case of an adverse event.

Don’t Miss Opportunities for New Business - Going forward, all multi-year contracts in the US and EU will require suppliersto show compliance with UDI and the new MDR standards.

This is a project that needs to be completed and a process that needs to be implemented within the organization for long-term compliance.

UDI SOLUTIONS

Coridian’s Solutions

• Provides the tools and expertise to gather, quality check, and manage your ongoing data requirementsProvides upload services to GUDID, EU MDR trading partners, EUDAMED, Global Data Synchronization Network (GDSN) and other global databases as they become availableEnhances your QMS. All changes to your data and labeling done in the system are maintained in the audit history with a time and user stamp for future referenceFutureproofs your compliance e�orts as new requirements or changes by regulatory authorities and trading partners are monitored and added as they become available

•

•

•

1. Compliance as a Service (CaaS)

CORIDIAN Technologies, Inc. 1725 Lake Drive West, Chanhassen, MN 55317 (952) 361-9980 CORIDIAN.com

Partners

Integration

2. Coridian Integration and Industry Expertise

Our experienced professionalservices team assists you with

data transfer and integration as well as

installation, training and service

Veri�cationCoridian provides veri�cation

systems and guidance onstandards to ensure your

barcodes comply with your Standard Operating Procedure

for veri�cation as required by GS1

Printers & LabelsCoridian’s experts help

you develop label and printing solutions designed to meet the

label lifespan requirements stipulated by government

and commercialauthorities

ScanningWe provide industry

leading data collection tools to help you meet the

new requirements and improve e�ciencies within

your organization

Bene�ts of the Coridian UDI Solution

Cost certainty for ongoing compliance with our �xed cost CaaS Ensures compliance consistency amidst a changing regulatory world and dynamic sta�ng challenges

••

Supports future organizational growthOne source for a complete UDI solution

••