In just over a year, it will be definitively mandatory to affix the UKCA mark on Medical Devices and IVDs to be marketed in the United Kingdom.

What to do to get the UKCA label?

UK from the CE mark to the UKCA mark. What to do?

Updated MHRA guidelines on registration and regulation of Medical Devices

At the beginning of 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidelines regarding Medical Devices registration and regulation in the UK. Changes reflect post-Brexit transitions expected in registration and regulation systems starting from 1st January 2022.

The two guidelines confirm that starting from 1st January 2022 there are no categories or risk classes that benefit from a period of grace: before being placed on the market, all Medical Devices must be registered with MHRA.

In addition to the registration of Medical Devices with MHRA, there is an important change in order to continue placing products on the UK market: the transition from the CE mark to the new UKCA product mark.

UKCA mark: what you need to know

The UKCA mark came into effect when the United Kingdom decided to leave the European Union in January 2021 and must be applied for at the designated Notified Bodies in the United Kingdom.

There is a transition period until 30 June 2023, when MHRA’s recognition and acceptance of the CE marking in the UK will end.

From 1 July 2023 the CE marking will have to be replaced by the new UK Conformity Assessed (UKCA) mark.

Starting from 1st July 2023, all Medical Devices and IVDs before being placed on the UK market (England, Wales, and Scotland) will therefore need to be re-labelled with the UKCA marking. The latter will not be recognised in the EU, EEA, nor in Northern Ireland.

For further clarification on the UKCA marking, please read the guideline  “Using the UKCA marking” which includes information such as the minimum size of the mark (at least 5mm), and the features of the logo.

Despite the deadline of 30 June 2023, companies can already use the UKCA mark to be able to demonstrate compliance of their devices with UK product legislation. Therefore, it is advisable to adapt as soon as possible to avoid any obstacles close to the deadline.

We also remind you that if you are a Manufacturer based outside the UK and want to market your products in the UK market, you must necessarily appoint the UK Responsible Person (UKRP).

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Choose Thema as your UKRP to adapt to the UK regulatory system

Please remember that Thema Staff can support you with Medical Devices registration in the UK, through the UK Responsible Person (UKRP) service.

To request the UK Responsible Person service or for a strategic-regulatory consultancy, contact our commercial department 👉