Legal News

New requirements added to medical device placing on market registration guidance

Published on: 27 September 2021
Published by LNB News

LNB News 27/09/2021

Document Information

Issue Date: 27 September 2021

Published Date: 27 September 2021

Jurisdiction(s): England, Northern Ireland, Scotland and Wales

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has added a section to its guidance on how to register medical devices for them to be placed on the markets in the UK. The additional section requires manufacturers to review their device registration details frequently to ensure they are correct and fully updated, in particular to provide UDI-DIs for devices, or else face suspension of device accounts.

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