Module 17 2024

05/12/2024

Chapter 4: Registration and UDI

Identification within the supply chain The regulations will require distributors and importers to cooperate with manufacturers, UKRPs, and public and private sector healthcare professionals and institutions to achieve an appropriate level of traceability for medical devices. Economic operators will be required to identify and record the following information: a. any economic operator to whom they have directly supplied a medical device b. any economic operator who has directly supplied them with a medical device c. any public or private sector health institution or healthcare professional to which they have directly supplied a medical device

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Chapter 4: Registration and UDI

Nomenclature Manufacturers will be required to provide the MHRA with the relevant GMDN nomenclature for their medical device as part of device registration. EMDN will not be used. Unique Device Identification ‘UDI’ will be defined within the regulations, and the intention is to utilize a definition that allows alignment with other jurisdictions, such as the EU . The following proposals will be included in the regulations: • To require manufacturers to assign UDIs to medical devices before they are placed on the market

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