On the 7th June 2019, The Official Journal of the European Union (OJEU) announced four UDI Issuing Entities for medical devices under the Medical Devices Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR). Here, we take a look at the “Basic UDI-DI” they will be in charge of; its role, the information it contains, where it can be found and how it will be used.
What is Basic UDI (Unique Device Identification)
The EC’s MDR defines the Basic UDI-DI as: “the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.”[1]
To put it simply, the Basic UDI is the device model or a grouping of devices that have similar properties. The Basic UDI data manages the properties and relationships for a device at the device model level, performing as a regulatory identifier. It is a code that identifies a dataset in Eudamed that describes the device.
Why is the Basic UDI needed?
The new MDR specifies that the certificates issued by a Notified Body (NB) must be able to unambiguously identify the device or devices covered (as defined by Annex XII of the MDR). This will support market transparency and ensure patient safety.
In reference to the Basic UDI information, the NB’s certificate will clearly identify “the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI.”[2] This is because the Basic UDI groups together devices that have the same:
- intended purpose
- risk class
- essential design
- manufacturing characteristics
How is Basic UDI connected to the UDI-DI?
A single Basic UDI can be linked to many UDI-DIs (DI issued to a specific model of a medical device), but a UDI-DI cannot be linked to multiple Basic UDIs.
Where can the Basic UDI be found?
Whilst the Basic UDI will not appear on any packaging, on the devices itself or in the supply chain, it can be found on the:
- Certificates (EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates from the Notified Body)
- Declaration of Conformity
- Technical Documentation
- Summary of Safety and Clinical Performance
- Certificate of Free Sale (Article 60(1) of MDR)
What is the format of Basic UDI?
The Basic UDI-DI code will have maximum 25 characters similar to the UDI. It will also include a check digit/character based on an algorithm defined by the Issuing Entity.
Who will issue the Basic UDI?
The Basic UDI will be issued by UDI Issuing Entities. These were identified by the EC in June 2019 as:
- Informationsstelle für Arzneispezialitäten (IFA GmbH)
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- ICCBBA
For more information on regulatory requirements for MedTech manufactures internationally, or for expert guidance navigating and strategizing your company’s approach to the EU’s MDR, contact The Tao of Excellence today for specialist advice and hands-on support with your company’s compliance and business development.
Deepa Rajagopalan
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+41 52 685 51 65
Email
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[1] Medical Device Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, Annex VI, Part C, The UDI System: Definition
[2] Ibid, Annex XII, Certificates Issued by a Notified Body, Chapter I
