MHRA guidance - Register medical devices to place on the market from 1 January 2021

How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland from 1 January 2021

Published 11 December 2020

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The guidance states that medical devices of all classes must be registered with the MHRA before being placed on the UK market. The dates by which the devices must be registered varies (e.g. Class IIb implantable devices must be registered by 1 May 2021 and Class IIb non-implantable medical devices must be registered by 1 September 2021).

We are not clear if the requirement to register medical devices with MHRA is applicable to finished (CE-marked) devices that are co-packaged with a medicinal product (e.g. needles, vial adapters, dosing droppers) where the co-packaged medicinal product is regulated under the Medicinal Products Directive. We are trying to understand if the manufacturer of these devices would be required to register these devices with MHRA before we can market a co-packaged combination product in the UK.

thanks
Federica Rusmini
Janssen Pharmaceuticals

Hi Federica, that is a good question, I would recommend you request more advice from MHRA via devices.regulatory@mhra.gov.uk.

The CE mark is suitable for EU markets only. The UKCA is the new mark for the UK. You may find these two links useful: