EU MDR UDI

Definition of UDI from the MDR

EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a new requirement to achieve the CE marking of a medical device.

The European Medical Device Regulation 2017/745 defines the UDI as follow:

(15)‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

Background

In 2013, the International Medical Device Regulators Forum (IMDRF) released a guide intended to globally harmonize device identification following the implementation of such kind of requirements by the US FDA. The regulatory frameworks of the US and the EU, follow these guidelines, although there are some discrepancies between the two systems regarding UDI data submission requirements/terminology as well as UDI labeling. As for the US UDI system, it is currently in the phase of implementation. The MDR will enter into force on 26 May 2021.

According to the UDI requirements, the device labelers – typically the manufacturers – are required to:

• include a UDI on device labels and packages (except where exceptions or alternatives are allowed); in the case that a device is intended to be used more than once and intended to be reprocessed before each use, the device labeler is also required to mark the UDI directly on the device.
• submit device information to the Global Unique Device Identification Database (GUDID). MDR and IVDR determine the legal requirements for the European UDI system. The UDI data must be provided on the EUDAMED database. The European UDI system will be phased in successively as scheduled, in a similar way to the US approach. Depending on the medical risk class, all marketed devices shall have a unique identifier by 26 May 2027. Contrary to the US FDA regulation, a new identifier – the Basic UDI-DI – has been introduced by the EU regulations. This new identifier allows the grouping of medical devices with similar features within the EU regulatory database. The submission of a product for market registration and/or approval to the competent authority assumes that the assignment was done by the medical device manufacturer or authorized representative.

When compared with the US FDA regulation, the EU regulations introduce a new identifier – the “Basic UDI-DI”. It allows to group medical devices with similar features within the EU regulatory database EUDAMED. It is assigned outside of the normal trade item supply chain. The assignment must be done by the manufacturer of the medical device or authorized representative before the product can be submitted for market registration/approval to the competent authorities.

Requirements (Art. 27) of EU MDR UDI

Composition of the UDI:

• UDI device identifier UDI-DI: specific to a manufacturer and a device
• UDI production identifier UDI-PI: unit of device production

Placement:

On the device (if reused or reprocessed) or on the label.

Storage:

Make sure it is stored by economic operators

Issuing agency:

Confirm the agency authorized to issue the UDI

UDI is placed on the device and the higher level of packaging.

Post-market:

Refer to the UDI when dealing with vigilance communication.

Declaration of conformity:

Refer to the basic UDI-DI in the declaration of conformity.

Technical documentation:

Maintain a list of all the UDI assigned

Deadline

 

Device as per Regulation (EU) 2017/745 (MDR)	Implantable devices and Class III devices	Class IIa and Class IIb devices	Class I devices
Placing UDI-carriers on the labels of devices MDR Article 123(3)(f), Article 27(4)	26 May 2021	26 May 2023	26 May 2025
Direct marking of the reusable devices MDR Article 123(3)(g), Article 27(4)	26 May 2023	26 May 2025	26 May 2027

 

Issuing agencies for EU MDR UDI

The following agencies have been authorized by the European Commission to issue UDI:

1. GS1 AISBL
2. Health Industry Business Communications Council (HIBCC)
3. International Council for Commonality in Blood Banking Automation (ICCBBA)
4. Informationsstelle für Arzneispezialitäten (IFA) GmbH

 

The first 3 agencies have also been authorized by the FDA for issuing UDI.

For instance, for GS1:

UDI regulatory requirements EU MDR and EU IVDR	GS1 standards Product Identification
Basic UDI-DI « New » level of identification in the EU	GMN (Global Model Number) No Application Identifier (AI) for regulated medical devices
UDI-DI Device Identifier (DI)	GTIN Global Trade Item Number
UDI-PI Production Identifier (PI) (if applicable)	AI Application Identifier (AI) • Expiration date AI(17) – e.g. 141120 • Batch – lot AI(10) – e.g. 1234AB • Serial number AI(21) – e.g. 12345XYZ
Production Identifier data will vary by medical device type and manufacturer current practice.
UDI-DI + UDI-PI = UDI	GTIN or GTIN + AI(s) = UDI

 

Transition process of EU MDR UDI – link with EUDAMED

As mentioned in MDCG 2019-4, EUDAMED will be effective at a minimum of 18 months from the official application date of the MDR.

However, UDI requirements implementation dates will not be affected. Only the recording in EUDAMED of the UDI information will be delayed according to the above.

 

You may go back to our EU MDR guide.

If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.