On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the medical device industry to help it comply with the requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) for unique device identifications (UDIs).
This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices1 (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices2 (IVDR).
The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
Guidelines address whether new UDI-DIs are required for changes to device packaging, such as making packages hold ten devices instead of five, and also state that UDI carriers must appear both on the device itself and on all packaging levels above.
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.
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