Published on Jul 27, 2022
UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.
This is a result of Brexit, and means that manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.
All medical devices have had to be registered with the MHRA (the Medical and Healthcare products Regulatory Agency) since 1st January 2021, although certain categories of medical device were granted a grace period of up to 12 months.
Those manufacturers based outside of the UK need to appoint a UK responsible person for managing compliance. This person can be a third-party entity, an importer or a distributor acting on behalf of the manufacturer. This person must also ensure that all technical documentation has been drawn up and must equally inform the manufacturer of any incidents or complaints about the device while in usage in the UK.
There are four classes of medical device in the UK:
If your device falls into Class I, then you can generally self-declare UKCA conformity, although it will have to receive official approval if it is sterile or has a measuring function.
This stipulates replacing the CE mark with the UKCA mark, limiting applicability to products for the UK market, changing reference of Notified Bodies to Approved Bodies and changing language references to English.
If you are selling medical devices in the UK, then your products need to have your UK name and address on the product or its accompanying documentation. And from 1st January 2023, the address of the UK-based manufacturer, importer or authorised representative must be permanently marked on the product and not just on the documentation or on a sticky label on the product.
You can display both the CE mark and the UKCA mark, and the UKCA mark is mandatory from 30th June 2023.
If you wish your CE mark to remain valid and your Notified Body certificate comes from a UK-based organisation, then you need to have your certificate re-issued by an EU-based Notified Body for your CE mark to remain valid.
UKCA markings can only come from a UK approved Body.
For a deep dive into UKCA marking for medical devices and how to achieve compliance, we’ve put together a full-day training course which will cover your legal obligations and will explain all of the UK medical device regulations and use of standards in the UK.
Published on Jul 27, 2022 by Andrea James