UK: postponed the mandatory UKCA marking. What happens now with Medical Devices and IVDs?

On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January 1st ,2023, for all the products placed on the UK market, but Medical Devices and IVDs, which transitional period deadline remains unchanged and scheduled for July 1st, 2023.

UK Postponed the mandatory UKCA marking. 
What happens now with medical devices and IVDs?
Postponed the mandatory UKCA marking.
What happens now with medical devices and IVDs?

What is the UKCA mark?

As known, in the aftermath of BREXIT, starting from January 1st, 2021 the United Kingdom is no longer a European Union State member.

As a result of this, at the beginning of 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) has published news ruled concerning placing and registration of a Medical Device in the UK.

Furthermore, the new UKCA product mark has been introduced – replacing the CE marking – which needs to be placed on products, including Medical Devices and IVDs, entering the UK market (England, Wales, and Scotland).

In this respect, MHRA has published an update of the guideline “Using the UKCA marking” to provide information on the application of the new UKCA mark.

This document gives, for example, details on the new rules to follow regarding the placement and the application of the UKCA marking, such as minimum size (5 mm at least) and logo characteristics (e.g., preservation of the proportion indicated in the facsimile and visibility requirements).

CE marking: how long will it be accepted in the UK?

MHRA will continue to accept CE marking on Medical Devices and IVDs until June, 30th 2023, as long as European Union legislation will not undergo any changes during this transitional period.

Starting from July 1st, 2023 along with other products placed on the UK’s market, Medical Devices and IVDs will need to have the UKCA mark in order to be placed on the UK market.

Companies can already use the UKCA mark, even before the deadline, to show its own conformity with United Kingdom product legislation.

Therefore, it is recommended to make the necessary adjustments as soon as possible in order to avoid any problem right before the deadline.

Why should you choose Thema to conform to UK legislation?

Thema experts are familiar with the UK market entry requirements and can give you the right support with the registration of Medical Devices in the UK and also providing the UK Responsible Person (UKRP) service which is required if the Manufacturer is based outside the United Kingdom and wants to sell devices in the British market.

Contact us for further information and to activate the service!

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Sources:

Guidance “Placing manufactured goods on the market in Great Britain”, MHRA, August 24, 2021

Guidance “Using the UKCA marking”, MHRA, August 24, 2021