The new system to prevent medical device counterfeiting

Unique Device Identification (UDI)

Injection pens to test insulin levels, contact lenses, patches, dental cutters, heart valves, and laboratory equipment for analysis: all these products are part of the medical devices category for which a big change is underway.

Many large and small companies are currently not ready to deal with the choices and the steps to be taken to face the new Medical Device Regulation.

MDR 2017/745 and IVDR 2017/746: the main challenges

MD classifications and UDI coding deadlines

UDI-DI and UDI-PI: the UDI structure

UDI printing: how, where, when and exceptions

Methods for the connection with EUDAMED

REGULATORY OVERVIEW

MDR and IVDR, the challenges ahead

The new “European Medical Devices Regulation” MDR 2017/745 came into force on May 26th, 2021, replacing the two previously existing EU directives (MDD and AIMDD); the new directive regulates the marking of medical devices by affixing a unique code for the devices traceability along the supply chain.

Together with MDR, on May 26th, 2022 the IVDR 2017/746 regulation for in-vitro diagnostics became effective too, replacing the previous IVDMD regulation.

2021 2023 2025 2027
UDI marking on DM Class III Class II Class I
Direct UDI marking on reusable DM Class III Class II Class I
UDI marking on in-vitro devices (IVD) Class D Class C e B Class A

CODING DEADLINES

Device classifications and deadlines

The introduction of the new regulations has a significant impact on many medical devices and in vitro devices companies, that is why the established compliance deadlines have been prioritized depending on the risk class to which the devices belong to.

The legislation identifies 4 categories of medical devices and 4 categories of in-vitro devices, classified in ascending order according to the degree of risk they represent to either the public health or the patient.

Find out more about the coding deadlines, and understand the category of your Medical Device.

STRUCTURE AND AUTHORIZED AGENCIES

UDI-DI, UDI-PI and GS1 agencies, HIBCC, ICCBBA or IFA

An identification code must be affixed to each medical device: the UDI is a unique code and is the “access key” to the product information recorded on EUDAMED. The UDI code can be numeric or alphanumeric and consists of 2 parts:

  1. Device Identifier (DI): It is a specific, fixed code (max 25 digits) that identifies a version or model of a device and its manufacturer
  2. Production Identifier (PI): It is a variable code related to the production data of the device, such as batch number, expiry date, manufacturing date, etc

UDI-DI codes are issued by authorized agencies such as: GS1, HIBCC, ICCBBA or IFA that can be freely chosen by the MD manufacturer.

WHERE TO PRINT, OBLIGATIONS AND EXCEPTIONS

UDI carrier: formats and types of codes

UDI is a unique code and is the “access key” to the product information recorded on EUDAMED. The word “unique” however, doesn’t mean that each device must be serialized individually, but that it must show a reference of the product placed on the market. Unlike the pharmaceutical sector, in fact, the serialization of devices in the EU is only mandatory for active implantable devices such as pacemakers and defibrillators.

The UDI Carrier is the “visible” format of the UDI and must be composed of readable characters in both HRI and AIDC formats. The manufacturer must have the UDI on the label of the device, on the primary packaging, and on all upper packaging levels that represent a sealable unit.

EUDAMED

Connection to Eudamed: when and how

EUDAMED is the IT system developed by the European Commission for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). The EUDAMED system includes the central database for medical and in-vitro devices which consists of six modules of which, to date, three have been activated.

The use of EUDAMED currently takes place on a voluntary basis for modules that have been made accessible. The connection to EUDAMED must take place within 6 months of the fully functional release of all platform modules.

It is possible to exchange data with EUDAMED in 3 different ways accordingly to the amount of data to be loaded, and the desired level of automation.

Discover our UDI solution portfolio