The MDCG guidelines are intended to help manufacturers implement UDIs under the MDR and IVDR


Posted May 23, 2022 | By Joanne S. Eglovitch

The Medical Devices Coordination Group (MDCG) of the European Commission published on May 20 a question and answer tips to help the medical device industry comply with Unique Device Identification (UDI) requirements under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).

The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for system and procedure packs and configurable devices, and whether UDI rules apply to retail outlets, promotional packs and marketing samples.

The MDCG explains that the guidance is not exhaustive and should be read in conjunction with the Commission’s recommendations FAQs on the UDI system and the obligations of operators, the European Medicines Agency (EMA) June 2021 questions and answers advice on the implementation of MDR and IVDR, Other MDCG UDI Guidelinesand the MDR and IVDR.

The guidelines indicate whether new UDI-DIs are needed for device packaging changes, such as changing the number of devices in a package from five to ten. The MDCG clarifies that these changes would require a new UDI-DI, stating that “a change in pack quantity would lead to misidentification of the device in this case and could lead to traceability issues in the event of an incident”.

The guidelines state that the UDI carrier must be placed on the label of the device itself and on all upper levels of packaging.

It further clarifies that for substance-based medical devices, even minor changes such as changes in formula quantity, require new UDIs, as well as the addition of claims that the products remain the same and look like the original product.

“Any modification likely to lead to erroneous identification of the device or ambiguity in its traceability requires 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 to device traceability if the same UDI-DI is used.

In other areas, the guidance specifies that devices used for marketing purposes, such as trade shows and exhibitions, do not need to have UDIs.

Under the MDR, UDIs must be affixed to all implantable devices and Class III devices no later than May 26, 2021, May 26, 2023 for Class IIa and Class IIb devices, and May 26, 2025 for Class I devices.

Under the IVDR, UDIs must be placed on the market by May 26, 2023 for Class D IVDs, May 26, 2025 for Class C and Class B devices, and May 26, 2027 for class A.


© 2022 Society of Regulatory Affairs Professionals.


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