The Medical Device Regulations (EU 2017/745 and EU 2017/746) incorporates the Unique Device Identification (UDI) system to uniquely track medical devices within the market supply chain. The prominent elements of the UDI system are specified in Article 27 to 31 and Chapter III and Annex VI of the regulations, but additional guidance is anticipated from the EU Authorities. The new UDI system will be implemented to all medical devices (apart from those which are custom-made and devices involved in performance study etc.) and is considerably founded on globally acknowledged guidelines and EU harmonized standards, particularly by utilizing definitions that are compatible with those used by major trade partners.
The Standard Notion of the UDI-DI for Medical Devices
The UDI is a sequence of alphanumeric or numeric letters that are made uniquely for a medical device and that is also compliant with a globally recognized medical device identification and coding standard. It permits the definite traceability of a particular medical device on the market.
- A device identifier (UDI-DI): It is a permanent code relevant to a version or model of a medical device design.
- Production Identifier (UDI-PI): It is a variable code relevant to the production data of the specific medical device in question. It includes information such as:
- Lot or batch number
- Serial Number
- Expiry date
- Production Date
The normal UDI-DI must be incorporated in the display of the medical device label, its packaging, and, in some cases, on the medical device itself.
Read our blog on UDI-DI for medical devices.
The Idea behind Basic UDI-DI
The EU regulations took a different route from the US FDA regulation and they present a new identifier, which is known as the “Basic UDI-DI”. The Basic UDI is envisioned to group medical devices with similar anticipated functions, objectives, risk levels, fundamental design, and production characteristics. Basic UDI-DI is an alphanumeric or numeric code.
The purpose of the Basic UDI-DI is to identify a group of medical devices uniquely.
The Basic UDI-DI is the most important access key for information of a medical device in the EUDAMED database and should be stated in the applicable documentation. Examples of documentation where it needs to be stated are:
- Certificate of Medical Device
- EU declaration of Conformity
- Technical Documentation
- Safety & Clinical Performance
- Vigilance Reports
- FSCA forms
However; Basic UDI-DI is not meant to be placed on the medical device label or its packaging or any item used for trading.
Read our blog about Data Elements of Basic UDI-DI
Clarification to identify the difference between Basic UDI-DI and Normal UDI-DI
The normal UDI-DI will be constructed by different components for example:
- Company name or trade name
- Device model or version
- Device labeling for single-use, sterile packaging, and requirement for sterilization before application
- Devices quantity packed in a package
- Critical cautions or contra-indications (for instance covering latex or DEHP etc.)
Any modification to any of these elements will therefore mandate an update in the normal UDI-DI wherever it is needed. On the other hand, any change in the above components will mandate a new UDI-DI, however, all the UDI-DI with little changes in the above details must be relevant to only one Basic UDI-DI fundamentally if there is no vital change in the product.
Responsibility for Assigning UDI
The producing company of the medical device is liable for fulfilling all requirements related to the UDI. It also includes the task of the incorporation of UDI and Basic UDI-DI, along with its registration in EUDAMED both for the UDI-DI and Basic UDI-DI. The responsibility also covers the implementation of the UDI carrier on the label of the medical device and also on its packaging or, in the instance of reusable medical devices; direct marking on the device itself.
Systems and procedure packs need to undertake a UDI registration process, as prescribed in Article 29(2) of the EU MDR. The maker of a system or procedure pack which is not a custom-made medical device needs to allocate the system or procedure pack with a Basic UDI-DI. They also are required to offer this information in the EUDAMED database along with the other pertinent core data elements, as enumerated in the MDCG guiding documents.
Timetable for UDI-DI and Basic UDI-DI Implementation
The responsibility for UDI implementation will be in effect from the anticipated date of application of the two new EU Regulations, which are 26 May 2022 for In Vitro diagnostic medical devices and 26 May 2021 for medical devices.
The responsibility for submission of UDI data in the EUDAMED database is lined up with the new modules of EUDAMED as planned by the European Commission as the Actor Module has already been released in December 2020. As it stands today, the EUDAMED is anticipated to be fully functioning in May 2022, and it is anticipated that the obligatory submission of UDI data for medical devices needs to be performed then in some timeline after the enforcement date.
Reporting Serious Incidents in EUDAMED
It needs to be noted that, on condition that that EUDAMED is fully functional, at any time in the near future, the manufacturers must know: The full registration of medical devices (Article 29 of MDR and Article 26 of IVDR) is still a pre-condition for the likely registration of their applicable serious incident in EUDAMED.
Alysidia is the market leader to help you out in compliance issues related to UDI-DI and Basic UDI-DI. Let us know where you stand and Contact us to schedule a call.