Module 17 2024

05/12/2024

Chapter 4: Registration and UDI

• To require reusable medical devices to bear a UDI carrier (for example, a barcode) that is permanent and readable after each process on the device itself. • To include requirements for Basic UDI device identifiers (UDI-DI) to identify medical device models It will not be required to assign UDIs before applying to Approved Bodies for conformity assessment. However, there is an amendment requirement for manufacturers of class III and some class IIb implantable devices to assign a Basic UDI-DI to these devices before applying to an Approved Body for conformity assessment, as the traceability benefits this brings are justified for these higher-risk devices.

The Organisation for Professionals in Regulatory Affairs

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Chapter 4: Registration and UDI

The regulations will define where the UDI or Basic UDI-DI is to be provided and require it to be provided in circumstances aligned with those stipulated in the EU MDR. GS1, HIBCC, ICCBBA and IFA will be designated as UDI issuing entities under the regulations . (Same as EU - MDR) Manufacturers will be required to keep an up-to-date list of all UDI’s they have assigned to medical devices as part of the technical documentation and be subject to the retention periods as outlined in the Conformity Assessment requirements. Economic operators and healthcare professionals, and/or health institutions will be required to store the UDI numbers of implantable medical devices. The regulations will contain clarity on the triggers that would result in a requirement to apply a new UDI-DI, although no details in the consultation document.

The Organisation for Professionals in Regulatory Affairs

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