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Needless to say, Brexit has had a major impact on numerous businesses. And that was no different for the life sciences industry. In this article, we will explain the impact of Brexit on the medical device market. We summarized the impact in 5 consequences for manufacturers that place medical devices on the UK market.
When we talk about the UK market, we mean the countries Scotland, England, Wales, and Northern Ireland. For Northern Ireland, the consequences of Brexit are slightly different. We will outline these in future blog posts and focus on Great Britain for now.
Introduction of the UKCA mark
First consequence is the disappearance of the CE mark and the introduction of the UKCA mark. From June 30, 2023, only UKCA-marked medical devices may be sold on the UK market and CE markings will no longer be accepted.
Until June 30, 2023, both CE and UKCA are allowed and dual marking of devices is also allowed. In addition to the new mark, UKCA-marked devices must also include the name and address of the UK Responsible Person on the label.
Designation of UK Responsible Persons
Regarding UK Responsible Persons, all manufacturers based outside the UK must designate a UK Responsible Person based in the UK, similar to the role of Authorized Person as you know it from EU regulations.
The responsibilities are set out in the UK version of the MDR (UK MDR 2002 amendment 2019, part II, provision “Registration of persons placing general medical devices on the market”). It is important that you designate the UK responsible person before registering your medical device with the MHRA.
Registration of your MD with the MHRA
That brings us to the third consequence: the registration of your medical device with the MHRA. Depending on the class and type, medical devices must be registered with the MHRA from 1 May 2021, 1 September 2021 or 1 January 2022. This applies to both UKCA- and CE-marked devices marketed in the UK.
Compliance with UK MDR 2002
Fourth, legislation is changing. Devices that currently comply with the EU MDD, EU IVDD, EU AIMDD or EU MDR must all comply with the UK MDR 2002 by July 1, 2023. The UK MDR 2002 is being harmonized with the EU MDR by an amendment introduced in 2019 and effective December 31, 2020. So make sure your medical devices comply with the UK MDR 2002 by July 1 2023.
Change in Notified Bodies
Fifth and final consequence of Brexit: all Notified Bodies with the EU MDD/IVDD/AIMDD designation that were based in the UK have lost their status as EU notified bodies. They are now UK approved bodies. The loss of EU Notified Body status means that all medical devices that manufacturers have certified with that Notified Body must be transferred to another EU Notified Body. This is the responsibility of the manufacturer.
Stay tuned for more Brexit news
With this short article, we wanted to give you a clear picture of the impact of Brexit on the medical device markets in the United Kingdom. We expect new developments around Brexit and medical devices and will update this article accordingly.
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