Questions and Answers on the Unique Device Identification system
23/5/2022
The MDCG published MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
A. UDI-DI
- Where the number of items in a device package changes, is a new UDI-DI assignment required?
A new UDI-DI assignment is required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI (created in compliance with the rules of the designated issuing entities7), is required in the case of any change of the following elements
- name or trade name,
- device version or model,
- labelled as single use,
- packaged sterile,
- need for sterilization before use,
- quantity of devices provided in a package,
- critical warnings or contra-indications (e.g. Containing latex or DEHP), CMR/Endocrine disruptors.
For example, where the number of devices in a package changes e.g. from 5 to 10, a new UDI-DI assignment to the package would be required. This is because a change in pack quantity would lead to a misidentification of the device in this case and may cause traceability issues where incidents occur.
- Are the UDI-DIs of single-use reprocessed devices the same as the original devices?
If reprocessing of single-use devices is permitted by national law, paragraph (2) of Article 17 provides that any natural or legal person who reprocesses a single-use device to make it suitable for further use, shall be considered the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers, including the ones referred to in Chapter III of the MDR. Namely, these include UDI assignment (e.g. Basic UDI-DI and UDI), UDI placement on the device label and all higher levels of packaging and UDI Eudamed registration obligations.
Consequently, when a single-use device is reprocessed in accordance with paragraph (2) of Article 17, given that the person responsible for the reprocessing assumes the obligations laid down Chapter III MDR, they shall assign to the reprocessed device a new Basic UDI-DI and UDI. The person responsible for the reprocessing should keep the UDI of the original product as part of the technical documentation and the organisation’s quality management system (QMS) to ensure traceability.
However, in case the single-use device is reprocessed in accordance with paragraph (3) of Article 17 (i.e. reprocessed and used within a health institution), a new UDI is not required and Commission Implementing Regulation (EU) 2020/1207 applies, in combination with other possible requirements in national rules on reprocessing of single-use devices.
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