The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, and whether UDI rules apply to retail point of sale, promotional packs and marketing samples.
MDCG explains that the guidance is non-exhaustive and should be read in conjunction with the Commission’s FAQs on the UDI system and the obligations of operators, the European Medicine Agency’s (EMA) June 2021 questions and answers guidance on implementing the MDR and IVDR, MDCG’s other UDI guidances, and the MDR and IVDR.
The guidance addresses whether new UDI-DIs are required for device packaging changes, such as changing the number of devices in a package from five to ten. MDCG specifies that these changes would necessitate a new UDI-DI, stating that “a change in pack quantity would lead to a misidentifying of the device in this case and may cause traceability issues where incidents occur.”
The guidance states that the UDI carrier needs to be placed on the label of the device itself and on all higher levels of packaging.
It further specifies that for substance-based medical devices, even minor changes such as formula quantity changes, necessitate new UDIs, as well as adding claims that the products remain the same and looks the same as the original product.
“Any changes that may lead to the misidentification of the device or ambiguity in its traceability require the assignment of a new USI-DI (Annex VII, Part C, Section 3.9). Although these desired changes are not specifically listed in section 3.9, they may pose a risk for device traceability if the same UDI-DI is used.”
In other areas, the guidance specifies that devices used for marketing purpose, such as trade fairs and exhibitions, need not have UDIs.
Under the MDR, UDIs must be affixed on all implantable devices and Class III devices by 26 May 2021, 26 May 2023 for Class IIa and Class IIb devices, and 26 May 2025 for Class I devices.
Under IVDR, UDIs must be placed on the market by 26 May 2023 for Class D IVDs, 26 May 2025 for Class C and Class B devices, and 26 May 2027 for Class A IVDs.
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