YOUR SELEON SPECIALIST

Peter Hartung
Head of BU Consulting, QM & RA, Quality Management Expert

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

 

Questions on this topic?

Send us a message!

 

25.07.2019

UDI - The Key for Organised Traceability

With the MDR, there are changes to many aspects of medical devices. The UDI-system is one of them and marks a turning point in the European method of traceability, as this system aims for a standardised and simple traceability. However, until the UDI-system is fully implemented, several important steps must be taken.

udi-alles-wird-jetzt-gekennzeichnet
udi-alles-wird-jetzt-gekennzeichnet
udi-alles-wird-jetzt-gekennzeichnet
udi-alles-wird-jetzt-gekennzeichnet

With the MDR, there are changes to many aspects of medical devices. The UDI-system counts to them. It leads to an improvement in exact traceability of medical devices and therefore enables, among others, to quickly correct negative effects from the placing on the market and market-surveillance of medical devices. However, until that system is fully implemented, several important steps must be taken.

 

UDI, what’s that again?

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. 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.

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]

< BACK TO OVERVIEW

 

Further entries from the "Quality management" category

Quality Management
25.07.2019

With the MDR, there are changes to many aspects of medical devices. The UDI-system is one of them and marks a turning point in the European method of traceability, as this system aims for a standardised and simple traceability. However, until the UDI-system is fully...

Quality Management
01.07.2019

Since January 1, 2019 the MDSAP-audit of your company has become mandatory for market access in Canada. Even though the other participating countries, such as the U.S., Brazil, Japan and Australia, do not have an audit obligation (yet), we cannot avoid it there. Our...

Quality Management
14.02.2019

Nothing works without software in the planning, control and implementation of medical technology projects. Tools are needed to develop efficiently and with minimal errors. But which tools are suited best?

Regulatory Affairs

Gaining approval for medical devices is complex and quite often also confusing. We bring clarity…

 

> Regulatory Affairs

Clinical Affairs

Clinical affairs of medical devices requires numerous evidences and evaluations. What we know about it …

 

> Clinical Affairs

Development Excellence

Product development of medical devices is subject to its own rules. We bring light into the darkness …

 

> Development Excellence