UK Conformity Assessment (UKCA)
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
All medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices from 1 January 2021 on the same basis as they do now until the new registration requirements start to apply to those devices
If you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person (Authorised Representative) who will take responsibility for the product in the UK.
UK Responsible Person
Manufacturers based outside the UK will be required to appoint a UK Responsible Person (UKRP) established in the UK. The UKRP will register relevant devices with the MHRA in line with the grace periods.
The UKRP will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
In addition to the registration requirements, the UK Responsible Person must:
Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable Regulations and inform the MHRA and, if applicable, the relevant Notified Body of that termination.
From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark has been affixed.
UKCA Importer
In cases where the Great Britain importer is not the UK Responsible Person, the importer will be required to inform the relevant UK Responsible Person of their intention to import a device. In such cases, the UK Responsible Person will be required to provide the MHRA with a list of device importers.
There are no additional obligations on distributors or suppliers of medical devices as of 1 January 2021. Existing obligations around storage, transportation and checking device labels for the CE marking or UKCA marking will continue to apply. The importer’s name and address will not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA mark.