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Regulating Medical Devices from 1 January 2021

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market. This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. For more information on the Regulatory system for medical devices in Northern Ireland, please see 'Regulation of medical devices in Northern Ireland.'

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. From 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. Manufacturers based outside the UK will need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.

We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill. We will take into consideration international standards and global harmonisation in the development of our future system.

From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices, including IVDs will change. Manufacturers wishing to place a device on the Great Britain market will first need to register with the MHRA. Where a manufacturer is not established in the UK, they will need to appoint a UK Responsible Person to register and act on their behalf.

In Great Britain, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023). The MHRA will only register devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK.

The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021. It will be possible to register devices ahead of the above dates, but there will be no legal obligation to do so. It will be possible for manufacturers to register devices of different classes, that are subject to different grace periods.

Failure to register from these dates will mean that you will no longer be able to lawfully place your device on the Great Britain market. If you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market.

The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks. The responsibilities of the UK Responsible Person will be set out in the UK MDR 2002.

It will be possible for an importer or distributor to act as a UK Responsible Person. From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling. UK Responsible Person details will not need to be included on labelling for CE marked devices.

Manufacturers will be able to use the UKCA mark on a voluntary basis from 1 January 2021. Class I device manufacturers will be able to self-certify against the UKCA mark from 1 January 2021. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.

UK Approved Bodies will not be able to conduct conformity assessments in relation to the CE marking other than for the purposes of the "CE UKNI" marking, which will be valid in Northern Ireland.

From 1 January 2021, the rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain. There will be a requirement, in most cases, to register devices with the MHRA and have a UK Responsible Person if the manufacturer is based outside the UK.

UKNI marking is sometimes referred to as the UK(NI) mark or the UK(NI) indication. After the transition period, most medical devices, IVDs and custom-made devices that are placed on the Northern Ireland market will need to be registered with the MHRA.

You will need to appoint a single UK Responsible Person within the UK by 1 January 2021 for devices that are placed on the Northern Ireland market. Great Britain manufacturers will be required to appoint an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. It will be possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person.

The timelines for registering medical devices with the MHRA are set out below. Where applicable, Class I devices, custom-made devices and general IVDs must be registered from 1 January 2021. For other device classes there will be grace periods for registering.

The MHRA will continue to be the Competent Authority for post-market surveillance activity for devices placed on the Northern Ireland market. From 1 January 2021, devices destined for the EU market will need to adhere to the relevant EU legislation. If you wish to place a medical device on the EU market after 31 December 2020 you will need to use an EU-recognised Notified Body.

Great Britain-based Authorised Representatives will not be recognised in the EU from 1 January 2021. If you are a manufacturer based outside the EU, you should appoint an Authorised Representative based in the EU or Northern Ireland. From 1 January 2021, you will need to ensure that your device meets EU labelling requirements.

Source: MHRA guideline on  Regulating medical devices from 1 January 2021

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