This page is no longer maintained. On 26 May 2021 the EUMDR entered into application and the MDD was repealed.
Simply stated, Unique Device Identification or UDI is the bar-coding of all medical devices on the European market using a standard format. It will be supported by a database which provides users and regulators quick access to information about the coded device.
In contrast to the current Medical Device Directive (MDD) which doesn’t mention UDI. The requirements associated with the introduction of UDI in the EU are present in many of the Articles and Annexes of the new European Union Medical Device Regulation (EU MDR). However, UDI is not a new topic. UDI is another example where the EU MDR simply brings European regulations up to date and into line with medical device regulations elsewhere in the world. UDI has been a requirement for certain Class III devices in the USA since mid-2014 for example. Also following the approach adopted in the USA, the UDI requirement in Europe will be phased in over several years.
According to Article 10 of the new EU MDR, UDI ranks among the basic obligations for all medical devices manufacturers, like preparing Technical Documentation. Article 27 contains the mandate to establish a UDI system for Europe. Article 28 contains the requirement to establish a UDI database. Article 29 requires Manufacturers to register their UDI in the database. While the specific data elements which make up the individual device UDI are listed in Part B of Annex VI.
As to the timing of the introduction of the basic UDI (Device Identifier) required for the documentation: Any Manufacturer wishing to comply with the new EU MDR can and should develop the basic UDI for their device without delay. As the UDI will be required for the new Technical Documentation (Annex II), for the new EU Declaration of Conformity (Annex IV) and for the new registration data (Annex VI, Part A).
Concerning the timing of the introduction of the basic UDI (Device Identifier) required for the documentation: Any Manufacturer wishing to comply with the new EU MDR can and should develop the basic UDI for their device without delay. The UDI is required for the new Technical Documentation (Annex II), for the new EU Declaration of Conformity (Annex IV) and for the new the registration data (Annex VI, Part A). However, manufacturers need not wait for the European system to be developed. Annex II, 1.1(b) says the device UDI based on “a” UDI system, rather than specifying the European UDI system. The interpretation being that the new Technical Documentation, the new EU Declaration of Conformity and the new registration can all be prepared based another UDI system, the system used in the USA for example. This is further supported by Article 120 (12) (Transitional provisions) which also confirms, prior to the designation of a UDI entity for the EU, formats published by GS1 AISBL, HIBCC and ICCBBA will also be recognised.
In contrast to the introduction of the basic UDI (Device Identifier) in the Technical Documentation, on the Declaration of Conformity and in the registration data. The introduction of the full UDI on labelling, which includes the production data, is in stages similar to the approach taken by the FDA.
According to Article 123 (f) and (g): The UDI labelling will be required for Class III devices from 26th May 2021. UDI labelling will be required for Class IIa and IIb devices from 26th May 2023. UDI labelling will be required for Class I devices from 26th May 2025. In the case of reusable devices the UDI is additionally required on the device itself, but only two years after the date of application on the labelling for the respective Class of device.
For additional information on UDI see the IMDRF UDI guidance document of December 2013.
For a company making pouches for packaging, how is the UDI regulation applied? Pouches are packed in quantities of 250 with a label on each package. The traceability is through the lot number and an incremental number on the pouch. Is this sufficient for a class I non-resusable medical device?
Thank you for your question about UDI requirements.
The EU MDR does not include such precise details. Please consult your specific UDI code-issuing entity.
If we change the ingredients of a medical device (ex: take out the latex), would be necessary to change the UDI. Which kind of change require a UDI change?
Thank you for your question:
Please consult your UDI issuing agency on the differences between a replacement product and a new product that would require a new identification.
Does someone knows if UDI is also request for non-European countries? Or what is the system South America, Asia, Australia, etc. use?
Hello,
I really enjoyed reading your review.
It had been advised that companies start getting their Basic UDI-DI now in this transition stage of MDD to the MDR. One of the requirements for Basic UDI-DI is the company’s “Single Registration Number”. The SRN cannot be allocated at the moment because the Eudamed has not been finalized or gone live. So as it seems, many unknowns are the cases here.
So in this case, how does a manufacturer go about this?
Thank you for your questions:
(1) The Basic UDI-DI or BUDI-DI (GS1 term Global Model Number) is decided by the manufacturer according to the rules of the UDI issuing agency.
(2) The SRN would have been provided by EUDAMED, but EUDAMED will not be available until 2022. In the meantime, registration will continue as a national process. You should confirm with your national competent authority whether they intend to issue an SRN in place of EUDAMED.
Hi I have a question regarding labeling changes, for virtual manufacturer – assuming the VM can comply with all technical requirements, who should appear on the label ? just the VM or should the OEM appear as well ?
Thank you for your question about the label in the case of a virtual manufacturer:
According to Annex I 23.2 (c), the name an address of the manufacturer must appear on the label. It can be either the OEM or a virtual manufacturer, whichever fulfils the definition and the obligations. But it can only be one, and it must be the same name and address of the manufacturer that appears on EU declaration of conformity, on the notified body certificate and in the EUDAMED database.
The EUMDR potentially requires up to three economic operators to have their names and addresses on the labelling, or in accompanying documentation; the manufacturer, and where applicable their authorised representative and importer. All these three parties are defined in the EUMDR and their obligations are defined. While the EUMDR doesn’t prohibit adding another economic operator name and address to the label, it should at least be clear in what capacity and for which purpose the name appears on the label.
I have a general question regarding the use of word “device registration” across many of the EU MDR related documents. Is “Device Registration” a synonym for the registration of “Basic UDI” and “Device UDI” or just the “Device UDI” or something completely different?
Thank you for your question. The majority of times “Registration” is used in the EU MDR it is referring to the generic two-step registration process. The first step is registering as an economic operator (See Article 31), the second step is registering the specifics of the device(s) (See Article 29).
Registering the device involves providing comprehensive details about the device itself (See Annex VI Part A Section 2), and its UDI details (See Annex VI Part B).
In case of OEM(ODM) products with private brand, what is going to happen? Apparently most of OEM products cannot meet up the requirement of MDR 2017 soon. Is there any possible way to keep private brand of OEM(ODM) products?
Thank you for your question. While terms like “own brand labeller”, “private labeller” or “virtual manufacturer” might be commonly used in business, they do not exist in the EU MDR nor did they exist in the original Directive. According to the definition in Article 2 (30), a company that markets a device under its name or trademark is a manufacturer. See also the 2019 guidance on virtual manufacturing from MHRA “… in practice there is no difference in the regulatory requirements applying to a manufacturer and a virtual manufacturer.” This was always the case, even under the Directive. The difference was in the past that the notified bodies and competent authorities were less strict applying the requirements under the Directive, partly also because the obligations of other economic operators such as importers and distributors were unclear. This was a grey area.
Under the EU MDR the obligations of the various economic operators are clearer. The only entities placing devices on the EU market are; a manufacturer (based in the EU), an importer (of a device from a non-EU manufacturer), or a person placing system or procedure packs on the market. Distributors have other obligations. But in practice, the choices for the own brand labeller/private labeller/virtual manufacturer have not changed compared to the Directive. Independent of any business to business relationships, the name and address of the legally responsible manufacturer must still be stated on the device labelling (alongside by the harmonised factory symbol), and that entity/company must fulfil the obligations of the manufacturer (Article 10). This means, either the “Original Equipment Manufacturer” (OEM) will be identified on labelling as the manufacturer (and must fulfil the manufacturer’s obligations). In that case the private labeller can act as an importer or a distributor, including having their name, address or trademark on the labelling. Or, the private labeller will be identified as the manufacturer on the labelling (alongside by the harmonised factory symbol), in which case the private labeller must fulfil the manufacturer’s obligations, even if some or all are outsourced or subcontracted to the OEM or other parties. The EU MDR has not changed any of this.