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Patrick Blumentritt
Head of Consulting North,
Quality Management & Regulatory Affairs

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

 

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17.02.2020

UDI - the countdown begins

The MDR comes into force on 26 May - and with it the UDI regulation. With new documents, the structures of the UDI and basic UDI-DI are also clarified.

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The Medical Device Regulation (MDR) comes into force on 26 May - and with it the UDI regulation. With new documents in the Commissions docsroom, the structures of the UDI and basic UDI-DI are also clarified. In addition, the European Commission has opted for a uniform EUDAMED nomenclature.

 

UDI Quick News

2020 ! It's there! With the MDR, the UDI system will become mandatory for all medical devices including in-vitro diagnostics in the EU from 26 May, except from custom-made devices and investigational devices.

Now, the European Commission has issued eight documents concerning UDI:

It is already known that the prerequisite for the implementation and creation of the UDI is a registration with one of the issuing entities. To that extent, these four issuing agencies have been designated by the Commission: GS1, HIBCC, ICCBBA and IFA. These four have provided the Commission with descriptions and examples of UDI and Basic UDI-DI. The UDI documents of the three first designated issuing agencies, GS1, HIBCC and ICCBBA, are known and were already available on the FDA website. The IFA GmbH was additionally designated as issuing agency for UDI-DI by the implementing decision of the EU Commission of 06 June 2019, thus the UDI documents of the IFA are completely new.

On the basis of the 4 published UDI documents, the differences in the UDI structure between the issuing agencies are easily recognizable. The initial character in HRI (human readable) format shows which issuing agency it is, e.g. GS1 code starts with "(01)", HIBBC code with "+", ICCBBA code with "=" and IFA with "11". Each issuing agency has its own rules on how a UDI-DI is built and how much data is stored in a code.

 

UDI - ok, but what is basic UDI-DI?

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

  • a beginning specific to an issuing agency (e.g. HIBC Basic UDI-DI characterized "++")
  • Manufacturer Code
  • Product group code
  • Check character.

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

The manufacturers of medical devices are responsible for maintaining a mapping between the basic UDI-DI and all associated UDI-DI.

 

EUDAMED - what's next?

Which data from the UDI must be included in the EUDAMED database has already been published. For a long time there was speculation about which nomenclature would be integrated into EUDAMED to ensure a uniform designation of medical devices. Two were available: 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 the CND as the basis for the EMDN (European Medical Device Nomenclature). EMDN will be integrated into EUDAMED for use by operators. EMDN will be accessible to all operators and will be available free of copyright.

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

In the meanwhile a short statement on the EUDAMED launch date was made by the commission:

  • The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022

The date of application of the MDR remains May 2020.

 

Basic UDI knowledge

The acronym UDI stands for Unique Device Identification and denotes a system of numbers with unique identification numbers for every medical device, what ensures a worldwide traceability of the product. However, this is not a completely new “invention”: since 2013, there is an UDI-system in the U.S. implemented by the FDA.

In the EU, the UDI-system will become mandatory for all medical devices including in vitro diagnostics, starting from 26 May 2020. For the eventual affixing on the product (UDI carrier) itself, there are the following deadlines:

  • For class III medical devices and implantable devices: 26 May 2021
  • For class IIa, IIb devices: 26 May 2023
  • For class I devices: 26 May 2025
  • For reusable products that must bear the UDI carrier on the device itself: two years after the date referred to for the respective class of device

A requirement for implementing and creating the UDI is the registration at one of the issuing entities (currently: GS1, IFA, HIBCC, ICCBBA).

 

What is part of the system?

Basically, the UDI-system does consist of two elements: the UDI number on every medical device and its packaging as well as the global UDI database.

The UDI number consists of two parts, the so-called UDI-DI and UDI-PI. The DI is the Device Identifier. It is the static part, for it contains the identification of the chosen issuing body, the identification of the manufacturer/labeller, the product reference code and it can contain an identification for a certain packaging level. The reference of the DI is thus also reflected in the central databases. The chosen issuing agency is recognisable due to the starting characters: GS1 codes start with (01), HIBBC codes with a “+”, ICCBBA codes with “=” and IFA codes with “11”. On the contrary, the PI - Production Identifier - is the dynamic part of the identification. It contains details on the expiration date, the lot number (LOT), the serial number (SN) and at times also details on the date of production. It depends on the particular product or product group which elements need to appear. Therefore, the UDI number is clearly readable for each single product, electronically as well as in plain text. The UDI marking consists of a bar code, a data matrix and the so-called RFID. Since the UDI-DI and -PI are intended for automatic capture, they must be coded in a standardised computer-readable form.

That is why the design of the label is exactly defined. There are specifications for the following elements:

  • bar code
  • colour of the bar code on the background
  • bar code height
  • bar-thickness
  • bar code length
  • bar code selection

Thus, it is necessary to look closely at these label requirements and to determine the appropriate printing technique.

In addition to UDI, a basic UDI-DI is assigned to make it easier to identify all associated products in EUDAMED. The basic UDI-DI is the main identifier of the product model, a DI at the level of the device unit of use and is created and purchased similar to UDI at the chosen issuing agency.

After creating the UDI number, the medical device must be registered in a central database (GUDID for the U.S., EUDAMED for Europe) by a person responsible together with the manufacturer. There, information must be entered on the economic operator (manufacturer, authorized representative, importer) and on the product itself.

The Global Unique Device Identification Database (GUDID) is a freely accessible database by the FDA. The manufacturer is obligated to enter information on the product and defined product characteristics. The required product characteristics can basically be found on the respective product label and are complemented by the number of approval.

The European Database on Medical Devices (EUDAMED) is the equivalent to the American GUDID. Upon registration, a Single Registration Number (SRN) is assigned automatically by the system, after the competent authority has registered the display of the address there. Currently, the German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information DIMDI) (according to §33 of the German Medical Device Act) provides the necessary data from the national medical device information system for the European database. In this way, all data from the German system is transferred into the European one.

 

What is the value of the UDI-system?

With this system it becomes easier to report devices, that became conspicuous during application. Thus, negative incidents can be tracked and analysed better, problematic products can be identified easier and improved faster or withdrawn from sale. This is a significant advantage and ensures a smooth process.

Further, by this means use errors can be reduced, too. For medical devices will be clearly identifiable by users and important information and characteristics will be made available in a standardised form. Meaning, if errors occur, the affected person will be able to report them with the most accurate product assignment.

The standardisation of the product-related part of the documentation in electronic health records, clinic databases and more is an additional advantage. This enables a solid traceability of medical devices that are already placed on the market as well as an analysis of new medical devices and new uses for medical devices that are already placed on the market.

Falsified devices and misuse of medical devices can be prevented by the UDI-system, because the UDI will become the basis of a global, secure and comprehensible distribution chain. That way, transparency is created across markets and countries for manufacturers, purchasers, users, patients and surveillance authorities.

 

How implementation takes place

For the implementation of the UDI-system an individual plan for every company is necessary, for depending on the company different challenges may occur. This is also given to the fact, that the implementation is rather complex and, as a result, it influences internal processes in the company and individual departments. Hence, the basis for a successful UDI implementation is a structured and planed procedure.

Within the project plan, individual phases have to be determined and tasks have to be assigned to responsible personnel. This plan should always be kept up to date and quality assurance should also be involved. Legal requirements have to be analysed and complemented by internal company requirements. Amongst others, core question from the analysis need to be answered, the date from which the company’s products are affected (see deadlines for affixing), if the labels need to be changed and which processes are affected by the UDI implementation and possibly need to be optimised.

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

It should be taken into account, that the process of planning and the transition to the UDI-system can take up between 6 to 18 months, depending on the company and its size.

We will happily support you with know-how and practicable, proven solutions in the implementation of the UDI.

 

Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

CONTACT YOUR SELEON SPECIALIST

[Inhalt: Englisch]

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