The Medical Device Regulation (MDR) will enter into force on May 26, 2020 – and so will the UDI regulation. With new documents in the Commission database, the structures of the UDI and basic UDI-DI have also been clarified. In addition, the European Commission has decided on a uniform EUDAMED nomenclature.

UDI Quick News

2020! It’s here! With the MDR, the UDI system will become mandatory for all medical devices, including in vitro diagnostic devices, in the EU starting May 26, except for custom devices and investigational devices.

Now the European Commission has issued eight documents on UDI.

General Specifications Change Notification (GSCN)

Appendix A: UDI HRI Formats – GS1 Sample UDI labels

HIBCC Basic UDI?DI

Appendix A: UDI HRI Formats HIBCC Standards

Coding and Labeling of Medical Devices Containing MPHO

Appendix A: UDI HRI Formats – ICCBBA Standards

Basic UDI-DI – IFA Standards

Appendix A: UDI HRI Formats – IFA Standards

It is already known that the prerequisite for the implementation and creation of the UDI is registration with one of the allocation bodies. These four allocation bodies have been identified by the Commission: GS1, HIBCC, ICCBBA, and IFA, and have provided descriptions and examples of UDI and Basic UDI-DI to the Commission. The UDI documents of the three first-named allocation bodies, GS1, HIBCC and ICCBBA, are known and could already be viewed on the FDA pages. IFA GmbH was additionally designated as an allocation body for UDI-DI by the EU Commission’s implementing decision of June 6, 2019, so IFA’s UDI documents are completely new.

Based on the four published UDI documents, it is easy to see the differences in the UDI structure between the allocation bodies. The initial character in HRI (human readable) format shows which allocation body it is, e.g. GS1 code starts with “(01)”, HIBBC code with “+”, ICCBBA code with “=” and IFA code with “11”. Each allocation body has its own rules on how a UDI DI is constructed and how much data is stored in a code.

General example:

 

UDI – okay, but what is basic UDI-DI?

The base UDI-DI is a registration number for a group of medical devices with the same intended purpose, same risk class, and comparable design and manufacturing characteristics. Four published documents describe how the basic UDI-DI is structured. Basically, a basic UDI-DI is composed of these four elements:

an allocation point-specific beginning (e.g. HIBC Basic UDI?DI characterized “++”)

manufacturer code

Product group code

Check digits

 

The basic UDI-DI is used to register the devices in the EU database EUDAMED. The base UDI-DI is referenced in the relevant documentation (i.e., certificates and technical documentation including instructions for use), but is not indicated on the product packaging or on the actual product itself.

Medical device manufacturers are responsible for maintaining a mapping between the base UDI-DI and any associated UDI-DI.

EUDAMED – what’s next?

Which data from the UDI must be included in the EUDAMED database has already been published. There was long speculation as to which nomenclature would be integrated into EUDAMED to ensure uniform designation of medical devices. Two were available for selection: the Italian CND (Classificazione Nazionale Dispositivi medici) and the GMDN (Global Medical Device Nomenclature).

In the new year, the European Commission has published two new documents. In one, the Commission announces the decision to use CND as the basis for EMDN (European Medical Device Nomenclature). EMDN will be integrated into EUDAMED for use by operators. EMDN will be accessible to all operators and available copyright-free.

The second document describes the background, principles and structure of CND.

There is also now a statement from the Commission on the launch date of EUDAMED:

The Commission concluded that it will not be possible to declare EUDAMED operational until the entire system and its various modules have reached full functionality and have undergone independent testing. Therefore, EUDAMED will be rolled out for medical and in vitro medical devices together, on the date originally envisaged for in vitro medical devices, i.e. May 2022.

This does not affect the application of the MDR from May 2020.

UDI Basic Knowledge

The acronym UDI stands for Unique Device Identification and describes a numbering system with its own codes for each medical device, which ensures the traceability of the product worldwide. However, it is not a completely new “invention”, because there has already been a UDI system in the USA since 2013, which was implemented by the FDA.

In the EU, the UDI system will become mandatory for all medical devices, including in vitro diagnostics, as of May 26, 2020. For the final attachment to the device (UDI carrier) itself, there are the following deadlines:

For Class III medical devices and implantable devices: May 26, 2021.

For class IIa, IIb devices: May 26, 2023

For class I devices: May 26, 2025

For reusable devices where the UDI carrier is to be placed on the device itself: two years after the stated date for the respective device class.

Prerequisite for the implementation and creation of the UDI is the registration with one of the allocation bodies (currently: GS1, IFA, HIBCC, ICCBBA).

Which parts does the system consist of?

Essentially, the UDI system consists of two elements: the UDI number on each medical device and its packaging, and the global UDI database.

The UDI number includes two parts, called the UDI-DI and UDI-PI. The DI is the device identifier. It is the static part, as it contains the identifier of the selected allocation body, the identifier of the manufacturer/labeler, the reference code of the device, and may also contain an identifier for a specific packaging level. The reference of the DI is thus also reflected in the central databases. The selected allocation point can be identified by the initial characters: codes of GS1 start with (01), codes of HIBBC with “+”, codes of ICCBBA with “=” and codes of IFA with “11”. In contrast, the PI, the Production Identifier, is the dynamic part of the identifier. It contains information on the expiration date, lot number and size (LOT), serial number (SN), and sometimes information on the date of manufacture. It depends on the particular product or product group which elements exactly have to occur. Thus, the UDI number is unique to each individual product electronically as well as readable in plain text. The UDI marking consists of a barcode, a data matrix or the so-called RFID. Since the UDI-DI and -PI are intended for automatic recording, they must be coded in a standardized, computer-readable form.

Thus, the design of the label is precisely specified. Specifications are made for the following elements:

Barcode

Color of the barcode to the background

Bar code height

Barcode thickness

Barcode length

Barcode selection

It is thus necessary to thoroughly address these label requirements and also determine the appropriate printing technique for them.

In addition to UDI, a base UDI-DI is also assigned to make it easier to identify all related products in EUDAMED. The base UDI DI is the primary identifier of the product model, a DI at the unit of use level of the product, and is created and acquired from the selected allocation body similar to UDI.

After the UDI number has been created, the medical device must now be registered in a central database by a responsible person together with the manufacturer (GUDID applies to the USA, EUDAMED to Europe). Information on the economic operator (manufacturer, authorized representative, importer) and the product itself must be entered there.

The Global Unique Device Identification Database (GUDID) is a freely accessible database of the FDA. Manufacturers are required to enter information about the product and defined product properties. The required product properties can essentially be found on the respective product label and are supplemented by the approval numbers.

The European Database on Medical Devices (EUDAMED) is the counterpart to the US GUDID. When registering, a Single Registration Number (SRN) is automatically assigned by the system after the responsible regulatory authority has registered the address notification there. Currently, DIMDI (according to § 33 Medical Devices Act) provides the required data from the national medical device information system for the European database. Thus, the data are transferred from the German system to the European one.

What is the benefit of the UDI system?

The system makes it easier to report products that have become conspicuous in their use. Negative incidents can thus be better tracked and analyzed, problematic products can be identified more easily and rectified or withdrawn from the market more quickly. This represents a considerable advantage and ensures a smooth process.

Furthermore, application errors can also be reduced in this way. This is because the medical devices will be clearly identifiable by users and important information and properties will thus be made available in a uniform manner. This means that when errors occur, the person concerned can report them with the most precise product assignment.

The standardization of the product-related part of the documentation in electronic health records, databases of clinics and others is an additional advantage. This allows for robust tracking to be established, both of medical devices that have already been placed on the market, as well as analysis of new medical devices and new applications for medical devices that are already on the market.

Counterfeiting and misuse of medical devices can be prevented by the UDI system, because the UDI will be the basis for a global, secure and traceable distribution chain. This will create transparency across markets and countries for manufacturers, purchasers, users, patients and regulatory authorities.

This is how the implementation takes place

Implementing the UDI system requires an individual plan for each company, as there may be different challenges depending on the company. This is also due to the fact that the implementation is relatively complex, affecting internal processes within the company and individual departments. The basis of a successful UDI implementation is therefore a structured planned process.

In the project plan, individual phases must be defined and tasks assigned to responsible personnel. This planning should always be kept up to date, and quality assurance should also be involved. Legal requirements must be analyzed and supplemented by internal company requirements. Among other things, key questions from the analysis must be answered as to when the company’s products will be affected (see deadlines for affixing), whether labels need to be changed, and which processes are affected by UDI implementation and may need to be optimized.

In the final step of the implementation, the conversion of all processes and systems to the UDI system takes place, i.e. the qualification of the IT components, validation and documentation, and a final test of the system.

It is important to remember that the process of planning and converting to the UDI system can take between six and acchtzehn months, depending on the company and its size.

We would be very happy to support you with know-how and practicable, proven solutions during the UDI implementation.

Please note that all details and lists are not intended to be exhaustive, are without guarantee and are provided for information purposes only.