Safety and quality are paramount in every aspect of the medical device industry. One way to ensure this is to implement UDIs for medical devices.
Issuing unique device identifiers with MDR compliance brings benefits not only to consumers but also to healthcare providers and healthcare systems. The UDI codes issued by designated UDI issuing agencies in Europe will support medical device manufacturers in complying with new regulatory requirements.
This article looks into the UDI system’s purpose and the EU MDR’s role. We’ll also discuss the designated agencies that can issue UDIs to medical device companies and how to comply with the requirements.
The Purpose of the UDI System
To address issues and deficiencies surrounding the medical industry, such as device malfunction, adverse events, and product recall, the Food and Drug Administration (FDA) established the UDI system.
Aside from facilitating the unambiguous identification of medical devices on the market, the UDI system can assist in developing data regarding the performance of different technologies and reduce the costs of purchasing and managing products.
The Europe (EU) Medical Device Regulations (MDR)
On May 5, 2017, the European Commission introduced the new EU MDR 2017/745 and IVDR 2017/746 to create a more unified and transparent system for medical devices in Europe. While the new EU MDR implementation was delayed due to COVID-19, everyone in the medical field was still impacted by changes in UDI requirements.
During the device’s production, manufacturers must submit the UDI-DI (Device Identifier) and additional product data to the digital information repository called EUDAMED. The public and healthcare professionals can access these data to learn more about medical devices available on the market.
What Is Included in the Unique Device Identifier?
The requirements of unique device identifiers under MDR 2017/745 include the following:
- Labelling
- Data submission to EUDAMED
- Traceability of UDI information
- Timelines for implementation
- UDIs issued by designated entities
The system applies to all medical devices except custom-made and performance study/investigational devices. The UDIs must be on a label that will be attached to a medical device or its packaging. It is basically composed of Basic UDI-DI, UDI-DI (Device Identifier), and UDI-PI (Production Identifier).
Designated UDI Issuing Entities
In the European Union, the DI portion of the UDI system is provided by an agency, much like the FDA’s UDI system for medical devices in the United States.
On June 2, 2019, the Official Journal of the European Union (OJEU) announced the UDI-issuing agencies to implement unique device identifiers under MDR for medical devices.
Here are the designated agencies for EU UDI issuance:
- Informationsstelle für Arzneispezialitäten (IFA GmbH)
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
Note: One of these four agencies (IFA GmbH) is based in Europe. The other three are the same ones the FDA selected for issuing UDI codes for the US market.
How Do Agencies Issue UDIs for MDR Compliance?
As described in MDR articles, the designated UDI issuing agencies will implement the unique codes necessary for UDI. The UDI structure will depend on the issuing agency selected by the medical device manufacturer. This is because the agencies operate different systems to implement UDIs.
To simplify our explanation, let’s suppose you choose GS1 to implement UDI codes. Based on the GS1 implementation rules, you must order GS1 Complete first. Within two working days, you can access your GCP (GS1 Company Prefix) and your GLN (Global Location Number), which you’ll need later to generate your UDIs.
For information on how to get a UDI from the issuing agency of your choice, we recommend you refer to their guidelines and select the agency with the most convenient process.
To clarify, the medical device companies DO NOT issue UDIs; instead, they provide their standardised numbers and codes, which will later translate to the UDI requirements.
In Conclusion
The Unique Device Identification System will allow accurate reporting, reviewing, and analysing adverse event reports to identify and correct defective medical devices. Furthermore, a fully implemented UDI system will:
- Enable health care professionals and others to more rapidly and precisely obtain necessary information concerning the characteristics of the device;
- Establish a global, secure distribution chain to address counterfeiting and diversion, as well as to prepare for medical emergencies;
- Create a globally recognised medical device identification system.
Talk to Vicki Partridge for More Information About Unique Device Identifiers under MDR
Ensuring your device meets the UDI system requirements of EU MDR is a critical part of the compliance process. To speed up the process and choose a UDI issuing agency, work with a medical device consultant like Vicki Partridge.
Vicki Partridge is a highly experienced and respected medical device regulatory affairs consultant who can represent you as a medical device manufacturer in importing and exporting therapeutic goods to and from Australia via the European, United States, Asian and New Zealand markets. Vicki can also provide further information about designated UDI issuing agencies for unique device identifiers under MDR or other aspects of UDIs.
You can contact Vicki Partridge’s office on +61 7 55295508 or complete the form, and we’ll get back to you.