EU system to identify medical devices for greater patient safety

The recommendation to European Union (EU) governments is designed to improve patient safety by using a common framework to identify medical devices so they can be easily traced.

ACT

Commission Recommendation 2013/172/EU of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union (Official Journal L 99 of 9.4.2013).

SUMMARY

Medical devices range from simple bandages to breast implants and highly sophisticated life-support machines. Legislation exists to guarantee the health and safety of patients and professionals who use them, but this does not include ways of tracing the items during their life cycle.

Common identification system (Unique Device Identification - UDI)

A common system has many advantages. It makes it possible to identify the products involved in any incident and arrange their recall, if necessary. Using the same data, such as a manufacturer's name and batch number, will enable this to be achieved across the EU, not just in one country. It should reduce medical errors where a device has been incorrectly used.

Benefits

The primary aim of the UDI system is to increase patient safety. It will also make it easier to identify fake products, improve distribution control and stock management of the items involved and accurately identify the devices used when treatment is reimbursed.

Efforts are under way to establish a globally accepted UDI system to replace different national and regional ones used in the EU. A single European UDI system will avoid unnecessary complications for manufacturers and users in the EU and will be aligned with international standards.

Requirements on manufacturers

Manufacturers must clearly identify the medical devices they produce with a UDI label or mark. The UDI will include an expiry or manufacturing date and a batch number. Importers and distributors must verify that this has been done before offering the equipment for sale.

Requirements on health institutions

Hospitals and other health institutions should keep an electronic record of the medical devices on their premises and when these are used for high-risk operations include information on which device has been used on which patient.

Centralised databank on medical devices

Information on manufacturers and the devices they produce will be centralised in the future European databank on medical devices (Eudamed) once it is established.

Last updated: 23.07.2014