UK Responsible Person

Medical Devices and In-Vitro Diagnostics

As of 1 January 2021, Non-UK based manufacturers became legally obliged to designate a UK Responsible Person to place their devices on the UK market.

Under the draft UK bill (“The Medicines and Medical Devices Bill 2019-21”) which is currently going through the UK Parliamentary process for ratification, the role of the UK Responsible Person will be decoupled from the role of the UK importer.

This means that it is highly recommended to designate a professional agency as UK Responsible Person.

As your UK Responsible Person, Obelis UK Ltd. will:

  • Register devices with MHRA
  • Ensure technical documentations have been drawn up
  • Keep a copy of technical documentations for inspection
  • Cooperate and Provide MHRA all information upon request
  • Inform the manufacturer of complaints and incidents
  • Represent the manufacturer
Appoint Obelis UK LTD. as your UK RP

Device Registration in the UK: Deadlines

Since 1 January 2021, all medical devices and in vitro diagnostic medical devices need to be registered with the MHRA before being placed on the UK market.
However, the registration of medical devices is staggered depending on the risk class of the devices:

  • Registration by 30 April 2021 for high risk devices:
    Class III, IIb implantable devices and AIM devices & IVD List A
  • Registration by 31 August 2021 for medium risk devices
    Class IIa and IIb non-implantable medical devices  & IVD List B and Self-testing
  • Registration by 31 December 2021 for low risk devices
    Class I medical devices  & general IVDs

Northern Ireland (NI) Market

Special rules will apply to devices placed on the NI market:
  • EU legislation will need to be followed & CE mark will need to be affixed or
  • In case a UK Approved Body performs the conformity assessment, a UKNI marking will be required;
  • The upcoming EU MDR and IVDR will apply as of their application dates;
Appointment of a UK RP as of 1 January 2021 & registration to the MHRA by:
  • 1 January 2021: Class I devices, custom-made devices and general IVDs
  • 1 May 2021: Class III and Class IIb implantables, AIM and IVD List A
  •  1 September 2021: Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs

UK CA Mark

Manufacturers will need to apply changes to their labels when placing them on the GB market. This includes the new UKCA Mark and the UK RP details on the label at the latest when the UKCA mark appears.
It is important to remember that devices bearing CE mark will not be required  to be relabeled with the UKCA until 1 July 2023. Furthermore, CE marking will be allowed to continue to appear on the label of devices made available on the GB market. This means that devices that bear a dual mark on their label can continue to be sold on the GB market event after the 1st of July 2023 by virtue of carrying the UKCA mark.

Current regulations

Currently, devices are regulated in the UK under:
• 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)

These directives are given effect in UK law through the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
These Regulations (in the form in which they existed on 1 January 2021) continue to have effect in Great Britain after the transition period. This means that since 1 January 2021, the Great Britain route to market and UKCA marking requirements is still based on the requirements derived from current EU legislation and Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

As your UK Responsible Person, Obelis UK Ltd. will:

  • Register devices with MHRA
  • Ensure technical documentations have been drawn up
  • Keep a copy of technical documentations for inspection
  • Cooperate and Provide MHRA all information upon request
  • Inform the manufacturer of complaints and incidents
  • Represent the manufacturer
Appoint Obelis UK LTD. as your UK RP

You might also be interested in

→ UK CA

→ Northern Ireland and the NI Protocol

→ BREXIT Compliance Tool Chart

→ UK Post BREXIT: Medical Devices

→ The Medical Devices Regulations 2002 – the applicable law in the UK regulating medical devices.

→ The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Obelis UK Ltd. will register your Medical Devices and IVDs in the UK within 6 working days.

Appoint Obelis UK LTD. as your UK RP