UKCA (United Kingdom Conformity Assessed) marking of medical devices was due to come into force in July 2023. This paced many Medical device manufacturers under huge pressure to meet the requirements within the timeline.
However, as many expected, The MHRA has now announced that the deadline will be extended to July 2024. A sigh of relief was heard from many manufacturers, who now have more time to ensure they have a smooth transition.
This is not a time to relax though, this extension should be used to ensure your company is fully prepared for the deadline.
Following Brexit and Great Britain leaving the EU single market, UKCA is to replace CE. The UKCA is mandatory for all products and indicates that it conforms to British legislation. It is simply Britain’s version of CE.
UKCA mark only applies in Great Britain (England, Wales and Scotland). CE mark continues in Northern Ireland as it is still in the EU single market for goods. Products that will be placed in both the British and NI market will need both UKCA and CE
The UK Government has concluded a consultation on the UK MDR 2022 (link). But, Specific details are yet to be published. The government has said it will be closely aligned with the 2017 EU Medical Device Regulations. Therefore we can assume there will be no big surprises once the UK MDR is published.
What immediate action needs to be taken?
If you are a medical device manufacturer based outside the UK and wish to place a device on the GB market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.
All medical devices, including in-vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market. A UK Responsible Person must undertake this for you
UK RepMed can Provide the above services, visit our website for more information
CE marking will continue to be recognised in Great Britain until 30 June 2024
Certificates issued by EU-recognised Notified Bodies will continue to be valid for the GB market until 30 June 2024
The EU no longer recognises UK Notified Bodies
UK Notified Bodies are not able to issue CE certificates - and have become UK Approved Bodies