New Regulations are Already Here
In the United States, the FDA has developed the Unique Device Identification (UDI) regulation. The FDA's UDI is a unique identifier for each medical device sold in the United States. The UDI along with information on the device’s components must be registered in a global database, known as the Global Unique Device Identification Database (GUDID).
The FDA ruled that labels and packages of class III medical devices, such as pacemakers and heart valves, be UDI compliant by September 24, 2014. The ruling means, in less than a year, data on the labels of class III devices must comply with the new FDA regulations. Similar rules for class II and I medical devices take effect on a progressive basis through September 24, 2020.
Other countries have had similar regulations in effect for several years. Japan started enforcing stricter regulations on medical devices in 2009. The European Union started regulating medical device requirements in 2012.
Advantages of Device Identification
The benefits of device identification go beyond complying with government regulations and ensuring knowledge of specific product and version. Many manufacturers are unaware of exact versions of devices which are in the hands of distributors and healthcare providers. Companies need to be able to maintain specific knowledge of devices for quality assurance, upgrades and patient and user communications. The obvious benefits of detailed and specific knowledge of each product variant in the case of a quality issue are well known. A device identification system provides the ability to connect the manufacturers, suppliers and the healthcare community with a shared electronic infrastructure to create clarity of each device’s specification for support and maintenance. The device identification system will ultimately enable sources of aggregated data to improve understanding of device performance, healthcare satisfaction and patient well-being.
What Do Medical Device Companies Do Now?
Medical device companies need to develop a strategy to conform to the new rules, implement changes and validate them. For some companies, adapting to new government regulations is a daunting task that often takes years to complete. For example, some of the world’s largest medical device companies have more than a thousand devices and sometimes dozens of versions of each one.
Help is Available
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to become UDI compliant. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
Ultimately, USDM Life Sciences will ensure a timely, efficient and smooth transition to the new regulations and do so in a controlled, documented process that ensures success, cost effective compliance with the regulations and continuity of production for critical products.
UDI Regulation Guidance and Corporate UDI Policy Development
- UDI Final Regulation Overview
- Key Industry Issues
- Client Status and Concerns
- Client Input on Corporate Issues and Concerns
- Regulation issues
- Individual product indentification issues
- Final Regulation Understanding and Corporate Policy
- Product Portfolio Analysis
- Class III
- Life Sustaining
- Class II
- Class I
- GUDID Access
We offer on-site team consultations, monthly team meetings, web training sessions and telephone support.