Along with consulting on regulatory and quality solutions, we aim to simplify terminologies and concepts in the life science industries for our clients. Unique device identification (UDI) for medical devices has been gaining visibility in the market, and is accompanied by the reoccurring questions “what is it?” and “do I need it?” We write here to provide a high-level overview of UDI for our medical device clients.
What is a UDI?
A UDI is an identification code used to identify and trace medical devices throughout their distribution and use.
The United States Food and Drug Administration (US FDA) requires a UDI on all medical device labels (including various levels of packaging) in human and machine-readable form (e.g. a barcode). Each type of device and every version or model of the device requires a separate UDI. A different UDI is also needed for each size, colour, material, style, and package size of a single device type.
A UDI is composed of two parts:
- Device identifier – identifies the labeler and model of the device
- Production identifier – identifies the lot/serial number, expiration and manufacturing date of the device
How are they obtained?
UDIs are assigned by accredited issuing agencies and information must be submitted to the Global UDI Database (GUDID) for each device.
Are there any exceptions?
There are a few products that are exempt from UDI requirements:
- Finished devices, labeled and manufactured prior to the compliance date that applies to that device
- GMP-exempt class I devices (e.g. hospital beds, surgical lamps, hearing aids, oxygen masks, toothbrushes, etc.)
- Devices used solely for research, teaching or chemical analysis and not intended for clinical use
- Custom and investigational devices
- Individual single-use devices (not available for implantable devices)
- Combination products with NDC numbers
- Veterinary devices
- Devices intended for export only (US manufactured devices only)
- Shipping containers
What are the compliance timelines?
Implementation of UDI began in September 2014 with highest-risk devices. The next upcoming deadline was initially published as September 24, 2018, but the FDA issued a letter on June 2, 2017 that extended the UDI compliance date to September 24, 2020 for certain class I and unclassified devices, including manual surgical instruments (e.g. clamp, dissector, scalpel blade) and mechanical wheelchairs.
What about Canada?
UDI is still not required for devices marketed in Canada. Health Canada has indicated that it is not thinking of enforcing any Canadian-specific requirements.
NHP Consulting can help your company navigate the UDI process in the United States. Please contact us for more information