UKRP and UKCA

We provide registration services to you as non-British manufacturer to place your medical devices, in vitro diagnostic devices and cosmetic products on the British market.
Medical Devices and In vitro Diagnostic Devices

• Registration of your company as manufacturer in the British Medicines and Healthcare products Regulatory Agency (MHRA) database.
• Registration of your medical device and/or IVD in the  MHRA database and keep the registration updated.
• Assistance with vigilance reporting with MHRA.

From July 1st, 2023, a UKCA mark will be required as well as providing a conformity assessment according to the British law.

To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.

The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. UK Responsible Person requirements for the Northern Ireland market are covered separately below. Importers and distributors are not required to appoint a UK Responsible Person.

Please note that the accounts of any former Great Britain-based Authorised Representatives that have not updated their role to UK Responsible Person on the MHRA registration system, as well as the accounts of any represented manufacturers, will be suspended from 1 January 2022 until the relevant UK Responsible Person has updated their role. For further information on registration requirements, please see guidance on registering medical devices.

The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. In summary, in addition to the above 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
• where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
• where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
• 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 appointed
• if the manufacturer acts contrary to its obligations under these Regulations:
  • terminate the legal relationship with the manufacturer; and
  • inform the MHRA and, if applicable, the relevant Approved Body of that termination.

There is nothing to prevent an importer or distributor from also acting as a UK Responsible Person.

The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.

 The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.

Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.

Where third party conformity assessment is required, a UK Approved Body is needed. However, manufacturers of non-sterile and non-measuring Class I devices and general IVDs can self-certify against the UKCA marking.

See the guidance Using the UKCA mark for further information.

UKCA marking requirements are based on the requirements of the relevant Annexes to the Directives listed below, which have been modified by Schedule 2A to the UK MDR 2002:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

Although the UKCA marking is available for use in Great Britain, a CE marking is needed for devices placed on the Northern Ireland market and EU rules need to be met.

Where allowed for in the relevant legislation, you can CE mark your device on the basis of self-certification for the purposes of the Northern Ireland market.

To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies are not recognised within the EU.