UK RP for Medical Devices and IVDs

UK Responsible Person for Medical Devices and In-Vitro Diagnostics

As of 1 January 2021, Non-UK based manufacturers will become 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.

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).

Read more:

☛ The Medical Devices Regulations 2002 - the applicable law in the UK regulating medical devices.

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

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

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