As with many things post-Brexit, conformity marking of medical devices and IVDs has become much more complex for those looking to enter the market in Great Britain or the UK.
What is conformity marking?
Conformity marking evidences that a product being sold has been assessed to meet high safety, health, and environmental protection requirements. A conformity assessment is carried out by the relevant Notified Body, and if it is met, a certificate is issued. Once a manufacturer has received the certificate, they can make their declaration of conformity and can affix the relevant mark to the product.
Before the UK’s withdrawal from the European Union, any medical device or IVD entering the UK market required CE marking.
So what’s changed?
Before getting into the details, it’s important here to make a definition between the United Kingdom (UK), which includes England, Wales, Scotland, and Northern Ireland, and Great Britain (GB), which consists of just England, Scotland, and Wales.
The UKCA mark has been introduced — confusingly — across the GB region, i.e. applicable to England, Wales, and Scotland only. This is already appearing on many products in people’s homes and workplaces, as well as on medical devices and IVDs.
Northern Ireland is still aligned with European regulations, so the EU’s CE mark is still applicable in this market.
What does this mean for products in the UK and GB markets?
A manufacturer wanting to place a product on the entirety of the UK market must be both UKCA and CE marked. For those only wanting to enter the GB market, only a UKCA mark is required. This must be completed by 1st July 2024 for medical devices and IVDs.
What if my product already has a CE mark?
If your product already has a CE mark, you must still obtain a UKCA mark. As the UK regulation is the same as the regulation in the EU before Brexit, there is not much work to do to “transform” to UKCA marking. A change in the Technical File is required to state that the product also meets the requirement for UKCA.
What about the new MDR/IVDR?
With the incoming more stringent regulation in the EU, obtaining conformity will be more rigorously assessed. However, UK regulations are not currently being updated to meet the same level of strictness as in Europe and therefore there will be some difference between the CE mark and UKCA mark in the future.
In June 2022, the UK’s MHRA released its “Government response to consultation on the future regulation of medical devices in the United Kingdom.” This response (see page 153) details a proposal to extend the transition period from 1st July 2024 for CE marked products to be available on the GB market for:
- three years if registered under the previous MDD/IVDD
- five years if approved under the new MDR/IVDR.
As this is at proposal stage, it is not confirmed. We will keep up to date with the latest from the government and MHRA and provide updates accordingly.
At Woodley BioReg, we can assist with both CE marking and UKCA marking, ensuring that you meet the correct standard for your intended market. Get in touch with us today to find out more.
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