What is a UK Authorized Representative?

Introduction to UK Authorized Representative

A UK Authorized Representative (UKRP; Authorized Representative is abbreviated as AR) refers to a legal person or entity located in the UK. Authorized in writing by a non-UK manufacturer, it acts on the manufacturer’s behalf to fulfill relevant regulatory obligations in the UK market and ensure products comply with UK regulatory requirements. After the UK’s Brexit, the role of UKRP is similar to that of an eu authorized representative (EU REP), helping non-UK enterprises complete product compliance registration and market supervision in the UK.

Why is a UK Authorized Representative Required?

(1) Legal Compliance Requirements

Since January 1, 2021, the UK has officially implemented the ukca (UK Conformity Assessed) marking to replace the ce marking. Non-UK manufacturers wishing to place relevant products on the UK market usually need to appoint a UKRP and ensure products comply with applicable regulations (such as the UK MDR 2002, UK PPE Regulation, etc.).

(2) Product Registration and Market Access

Certain product categories (such as medical devices, personal protective equipment, etc.) must complete registration procedures through a UKRP before entering the UK market to be sold in England, Scotland, and Wales.

(3) Regulatory Communication Channel

As the liaison between the manufacturer and UK regulatory authorities (such as the MHRA), the UKRP is responsible for incident reporting, compliance investigations, and other matters.

(4) Legal and Compliance Responsibilities

The UKRP must cooperate with the manufacturer to fulfill compliance obligations, including recall handling and document archiving.

What are the Responsibilities of a UK Authorized Representative?

①　Product Registration: Submit product registration information to UK regulatory authorities (such as the MHRA).

②　Technical Document Management: Ensure technical documents (such as technical files, Declaration of Conformity, etc.) comply with UK regulations and are available for regulatory review.

③　Incident Reporting and Regulatory Communication: Report to relevant authorities and assist in investigations in the event of serious incidents.

④　Labeling and Compliance: Ensure the UKRP’s name and contact information are accurately marked on product packaging and instructions, and meet ukca marking requirements.

⑤　Post-Market Supervision: Cooperate with UK regulatory authorities in market supervision, such as product recalls and compliance inspections.

Which Products Require UK Authorized Representative Information?

According to UK regulations, the following product categories usually require the appointment of a UKRP and must comply with corresponding UK regulatory requirements:

1. Medical Devices

· Regulatory Basis:

①　UK Medical Devices Regulations 2002 (UK MDR 2002) (revised version, applicable to England, Scotland, and Wales)

②　The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Brexit-adjusted regulations)

· Scope of Application:

①　Class I, IIa, IIb, and III medical devices

②　In Vitro Diagnostic Devices (IVDs)

③　Custom-made Devices

· UKRP Requirements:

Non-UK manufacturers must appoint a UKRP and register with the MHRA (Medicines and Healthcare products Regulatory Agency).

2. Personal Protective Equipment (PPE)

· Regulatory Basis:

①　The Personal Protective Equipment (Enforcement) Regulations 2018 (UK PPE Regulations)

②　UK Regulation (EU) 2016/425 (adopted and adjusted by the UK)

· Scope of Application:

①　Protective masks, protective clothing, safety gloves, goggles, helmets, etc.

②　Must meet ukca certification requirements (the original ce marking requires a phased transition)

· UKRP Requirements:

Non-UK manufacturers must appoint a UKRP to ensure products comply with UK PPE regulations.

3. Construction Products

· Regulatory Basis:

①　The Construction Products Regulations 2019 (UK Construction Products Regulations)

②　UKCA marking replaces CE marking (mandatory since January 1, 2023)

· Scope of Application:

①　Construction steel, cement, glass, fire-resistant materials, etc.

②　Must comply with UK national standards (such as BS EN series standards)

· UKRP Requirements:

Non-UK manufacturers need to appoint a UKRP to ensure products comply with UK building regulations.

4. Toy Safety

(1) Regulatory Basis:

The Toys (Safety) Regulations 2011 (UK Toy Safety Regulations)

UKCA certification requirements (replacing CE marking)

(2) Scope of Application:

Children’s toys (such as plastic toys, electronic toys, plush toys, etc.)

Must meet UK Toy Safety Directive requirements

(3) UKRP Requirements:

Non-UK toy manufacturers need to appoint a UKRP to ensure compliance with UK market access requirements.

5. Electrical and Electronic Equipment (EEE) and Radio Equipment

(1) Regulatory Basis:

The Electrical Equipment (Safety) Regulations 2016 (UK Electrical Equipment Safety Regulations)

The Radio Equipment Regulations 2017 (UK Radio Equipment Regulations)

(2) Scope of Application:

Household appliances, IT equipment, lighting fixtures, wireless communication equipment, etc.

Must meet UKCA or UKNI (Northern Ireland market) certification

(3) UKRP Requirements:

Non-UK manufacturers need to appoint a UKRP to ensure products comply with UK Electromagnetic Compatibility (EMC) and radio regulations.

6. Pressure Equipment and Gas Appliances

(1)Regulatory Basis:

①　The Pressure Equipment (Safety) Regulations 2016 (UK Pressure Equipment Safety Regulations)

②　The Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 (UK Gas Appliances Regulations)

(2)Scope of Application:

①　Boilers, pressure vessels, gas stoves, etc.

②　Must meet UKCA certification requirements

(3)UKRP Requirements:

Non-UK manufacturers need to appoint a UKRP to ensure products comply with UK safety standards.

7. Other UKCA-Regulated Products

Including:

①　Measuring Instruments

②　Recreational Craft

③　Lifts

④　ATEX Equipment (must comply with UKEX certification)

⑤　UKRP Requirements:

Non-UK manufacturers need to appoint a UKRP in accordance with specific regulatory requirements.

8. Exception (Northern Ireland Market)

Under the Northern Ireland Protocol, EU regulations still apply in Northern Ireland, requiring an EU Authorized Representative (EU REP) instead of a UKRP.

Products entering the Northern Ireland market must use the CE or UKNI marking.

UK Authorized Representative Application Process

(1) Select a Compliant UKRP

Ensure the UKRP is located in the UK and has relevant industry experience (such as in medical devices, PPE, etc.).

Compliant UKRP service providers can be found through professional consulting firms or legal representatives.

(2) Sign a Mandate Agreement

The manufacturer and UKRP sign a formal agreement specifying the responsibilities of both parties (such as registration, incident reporting, etc.).

(3) Submit Technical Documents

The manufacturer must provide product technical files, Declaration of Conformity (DoC), ukca certificate, etc., for UKRP review.

(4) Complete UKRP Registration

The UKRP submits manufacturer and product information to UK regulatory authorities (such as the MHRA) to complete registration.

(5) Update Product Labels and Instructions

Ensure the UKRP’s name and contact information are marked on product labels, packaging, or instructions.

(6) Continuous Compliance Maintenance

The UKRP assists the manufacturer in handling subsequent matters such as regulatory updates, market supervision, and incident reporting.