UKCA Mark: Medical Devices
The UK has left the EU and the Brexit transition period comes to an end on the 31 December 2020.
The key points of what you need to do to place a medical device on the UK and EU markets after 1 January 2021 was recently announced on Medicines and Healthcare products Regulatory Agency (MHRA) website. Please note the below information is for guidance only and is subject to change and parliamentary approval.
If you are a UK-based manufacturer supplying to the UK market only
If not registered yet, you will need to register your device with the MHRA. According to the grace period that varies for each type of device based on the risk classification (details can be found here).
Both MDD and MDR certification will continue to be accepted in Great Britain. After 30 June 2023 the UK Regulation will come into force and UK Conformity Assessed (UKCA) mark will be necessary. MDR will not be mandatory in Great Britain.
If you are based in the Northern Ireland, CE mark is required and therefore, MDR will be mandatory from 25 May 2021. Valid MDD certificates will continue to be accepted until their expiry date and no later than 25 May 2024, as long as there are no substantial changes to the device, which will then require MDR certification.
If you are a UK-based manufacturer supplying to the EU market
After 1 January 2021 you will need an EU or NI based authorised representative.
You will also be required to demonstrate compliance with CE mark (MDD/MDR). Note that products carrying both the CE mark and the UK(NI) mark cannot be placed on the EU market.
If you are outside the UK and supplying to the UK market
You will have a grace period to register your device with the MHRA.
Different rules apply for Great Britain and Northern Ireland. If you are supplying to Great Britain, the CE mark will continue to be recognised until 30 June 2023. After that, the UKCA mark will be required, and a dual certification (CE + UKCA) will be accepted.
If you are supplying to the Northern Ireland (NI) market only a CE mark will be required and MDR will be required after 25 May 2021. MDD certified devices can continue to be placed on the NI market as long as it is valid or until 25 May 2024, whichever comes first and as long as there are no substantial changes to the device, which will then require MDR certification.
You will have to register a UK-based responsible person and for more details on rules and responsibilities check the government page by clicking here.
For more details on how to register your device with MHRA click here.
The MHRA is constantly updating the guidelines and for the latest information please check the government advice on Regulating Medical Devices from 1 January 2021.