Medical Device Regulation

Unique Device Identification (UDI)

What is Unique Device Identification and what does it do?

Unique Device Identification (UDI) marks and identifies individual medical devices throughout their distribution and product life.

The UDI system was initially developed to make it easier to identify and trace devices (important in a regulated industry). Today, it also helps with procurement and reimbursement.

How does it work?

A UDI is made up of a device identifier (DI) and a production identifier (PI). The device is marked with the UDI using automatic identification and data capture (AIDC) - most often, a bar code. Most often, it complies with standard GS1, which the NHS mandates for e-business procurement.

UDI across the world

UDI’s importance can’t be overstated. From the start, it has been used as a global system to support patient safety and supply chain efficiency.

The USA was first to incorporate it into national regulations (through an FDA Rule in September 2013).

The EU’s new Medical Device Regulations will require virtually all devices to carry a unique identifier with effect from date of application which is likely to be mid 2020.  This will be introduced progressively, through a risk-based approach (highest risk devices first).  UDI will also underpin the EUDAMED database.

Importantly the International Medical Device Regulators Forum (IMDRF) has also incorporated a requirement for UDI in guidance which states that the “UDI System is intended to provide a single, globally harmonised system for positive identification of medical devices”. The objective is for regional UDI databases to be interoperable. UDI is therefore a key component in the development of global trade in medical devices.

The MedTech industry has recently issued the following position statement, which ABHI fully supports:  The medical device industry is highly supportive of a reinforced regulatory approach around the traceability of medical devices. Improved traceability will undoubtedly improve patient health and safety. Effectively implemented system will assist in the fight against counterfeiting, facilitate better control of the whole supply chain, facilitate improved stock management and has a potential of addressing reimbursement issues. However, in order to reach the goal of a globally harmonised UDI system and enable the desired level of traceability, it is critical that the systems are implemented without regional or national differences.”