Module 17 2024

05/12/2024

Chapter 4: Registration and UDI

Great Britain database on medical devices “The government is focused on establishing a more comprehensive registration database for medical devices, which will include UDI information. We remain focused on exploring whether and how best this database can operate” GB version of EUDAMED? Registration of medical devices When registering a medical device with the MHRA, manufacturers or their UK Responsible Person will need to provide the address of their registered place of business and a description of each category of medical device concerned. The regulations also define what information will and will not be required to be submitted when registering a medical device with the MHRA

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Chapter 4: Registration and UDI

A phased introduction of new registration requirements commensurate with a device's risk classification. This will be similar to the phased approach taken to introducing new medical device registration requirements in 2021 when compliance timeframes were set in accordance with device classes. All registration data will be publicly available to enable more informed choices about the use of medical devices, excluding personal information and commercially sensitive information, in compliance with the UK GDPR. No decision has yet been made on whether manufacturers have to register with the MHRA before applying to an Approved Body for conformity assessment and for the Approved Body to verify this registration.

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