Updated UK Regulation for medical devices
On 31 January 2020, the United Kingdom (UK) left the EU. As a result of this Brexit, different product legislation applies within the UK. In this update you can read which (transitional) rules apply to medical devices.
UK Responsible Person
Manufacturers who are not based in the UK and who want to market a new medical device in the UK must first appoint a UK Responsible Person. This is not the case for importers and distributors.
The UK Responsible Person must register the medical device with the Medicines and Healthcare products Regulatory Agency (MHRA) before it is made available on the market. The MHRA is responsible for regulating the UK medical devices market.
For devices that were already available on the UK market before Brexit, there was a transition period for this registration. The registration period was – dependent on the risk class of the device – four to twelve months.
CE marking or UKCA marking: New UK medical device regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the implementation of the new UK medical device regulation will be delayed by a year to July 2024. The UK government needs longer to implement the new regulations and to minimise the risk of interruptions in supply for UK patients.
This delay means that manufacturers can continue to place CE marked medical devices on the UK market until 30 June 2024, instead of 30 June 2023. From 1 July 2024 a UKCA marking is therefore required.
Different rules for Northern Ireland
Northern Ireland follows its own post-Brexit protocol. The rules for the Northern Irish market are therefore different to those for the British market (England, Wales and Scotland). This means that, unlike in Great Britain , the MDR does apply in Northern Ireland and CE marking is required for medical devices placed on the market in Northern Ireland. In some cases, another conformity marking (the UKNI marking) is also required. Certain medical devices and bespoke devices placed on the Northern Ireland market must also be registered with the MHRA.
Need some help?
Do you need help appointing a UK Responsible Person or replacing your CE marking with UKCA marking? Or do you have questions about placing your products on the market in Northern Ireland? Then please contact one of our experts. We’d be happy to help you!