Information on the Unique Device Identifier (UDI)
The "UDI system" described in the new Medical Device Regulations (EU) 2017/745 & (EU) 2017/746, allows for the identification and facilitates the traceability of technological devices, and consists of the following:
a) creation of a UDI that includes:
- a UDI device identifier (‘UDI-DI’) that refers to a specific manufacturer and product,
- a UDI production identifier (‘UDI-PI’) identifying the manufacturing site of the device and, where applicable, the packaged devices;
b) placing the UDI on the labeling or packaging of the device,
c) storage of the UDI by economic operators, health units and health professionals, in accordance with the terms of the legislation,
d) creation of an electronic system for the unique identification of a technological device ("UDI database").
UDI carriers are placed on the device label and on all upper levels of packaging. Upper levels of packaging are not meant to include containers.
The obligation to place the UDI carrier applies according to the following timetables:
Positioning of carriers UDI on product labels in accordance with Regulation (EU) 2017/745 (Article 123):
– Implantable products and class III products: 26 May 2021
-Class IIa and IIb products: 26 May 2023
-Category I products: 26 May 2025
Direct marking of reusable products (article 123):
-Implantable products and class III products: 26 May 2023
-Class IIa and IIb products: 26 May 2025
-Category I products: 26 May 2027
Positioning of carriers UDI on product labels in accordance with Regulation (EU) 2017/746 (Article 113):
-In Vitro Diagnostics I/P category D: 26 May 2023
-In Vitro Diagnostics I/P category C and B: 26 May 2025
-In Vitro Diagnostics I/P category A: 26 May 2027
See all dates by product category at the link below. //webgate.ec.europa.eu/udi-helpdesk/en/udi-carrier/deadlines.html
Note that a new UDI-DI is required whenever there is a change that could lead to incorrect identification of the device and/or uncertainty in its traceability· in particular, any change to one of the following data elements of the UDI database requires a new UDI-DI:
a) name or trade name,
b) variant or model of a technological product,
c) a product labeled for single use,
d) product in sterile packaging,
e) need for sterilization before use,
f) quantity of technological products in the packaging,
g) critical warnings or contraindications. e.g. if it contains latex or DEHP.
Additional information about the unique device identifier UDI can be found on the European Commission website.
//webgate.ec.europa.eu/udi-helpdesk/en/welcome-to-eu-udi-helpdesk.html
The UDI Helpdesk provides useful information on UDI performance, the UDI-Carrier, a frequently asked questions (FAQ) form, guidance documents and Videos.
Evaluation Directorate – Health Equipment Evaluation Department
