The MDR will take effect in approximately one month. On the same date, May 26, 2021, UDI requirements will begin to apply to implantable devices and Class III devices, meaning UDI carriers must be placed on the device label and on all higher levels of packaging. For medium- and low-risk medical devices, there is more time, i.e., 2 years after on May 26, 2023 for Class IIa and IIb devices and 4 years after on May 26, 2025 for Class I devices, for manufacturers to develop a best and appropriate solution to meet MDR UDI requirements.
Under the EU MDR and IVDR, a total of 4 UDI issuing bodies are designated with reference to Commission Implementing Decision (EU) 2019/939. These are GS1, HIBCC, ICCBBA and IFA, with IFA being an addition to the FDA designated issuing body. There is no superiority of one or another UDI issuing body or UDI format, but there are certain limitations that the manufacturer should consider when selecting the UDI format issued by the issuing bodies and that are related to, for example, the size, type and distribution channel of the medical devices.
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