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Please note this is an extract of the original bulletin.

 

Borderline products: how to tell if your product is a medical device and which risk class applies

Page summary:
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.

Change made:
An additional section ‘Annex A – MHRA borderline determinations’ has been added to assist manufacturers to arrive at the appropriate classification for their products.

Register medical devices to place on the market

Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

Change made:
Updated ‘Manufacturer and Device and Product and Importer Attributes’ to July 2023.

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