Welcome to UKARA

The UK Authorised Representative / Responsible Person Association

Discover

UKARA is the trade association of UK Authorised Representatives (also known as Responsible Persons)


We verify, support and promote persons or businesses representing manufacturers of products placed on the market in Great Britain and certain British territories under applicable laws in Britain requiring competent and qualified persons.

UKARA was originally founded to serve as an association of UK Authorised Representatives for the medical device industry but now represents all UK Authorised Representatives / Responsible Persons (UKAR/RP).

About us

UKARA is the trade association of UK Authorised Representatives (also known as Responsible Persons)


UKARA formulates requirements whereby persons can be qualified and credentialled as a formal organisational resource to industry, covering all sectoral requirements under laws in the UK.

Any natural or legal person eligible to serve as a UKAR/RP under Great Britain laws may register as a provisional member with UKARA. Applicants must demonstrate and maintain minimum requirements founded on laws in force on or from 1 January 2021, and where necessary or encouraged by the UK government immediate by appoint a UKAR/RP now.

Only persons fulfilling membership criteria, including competence qualifications and proficient documented systems, will be able to achieve UKARA practitioner membership.  

Members

Quality First International Limited

Suites 317 & 318

Burford Business Centre

11 Burford Road

E15 2ST

London

Great Britain

enquiries@qualityfirstint.com

Visit Website

Range of technologies

EU & UK Authorised Representative / Responsible Person

  • Medical Devices
  • Cosmetics
  • Toys
  • General Product Safety
  • Electrical and Low voltage
  • Jewellery
  • Pressure Equipment
  • Machinery
  • Foods
  • PPE

International Associates Limited

Centrum House

38 Queen Street

Glasgow

G1 3DX

Scotland

Visit Website

Range of technologies

EU, UK & Swiss Authorised Representative / Responsible Person

  • Medical Devices
  • Cosmetics
  • Toys
  • General Product Safety
  • Electrical and Low voltage
  • Jewellery
  • Pressure Equipment
  • Machinery
  • Foods
  • PPE

Flen Health UK Limited

1 Northumberland Avenue

Trafalgar Square

Other

London

WC2N 5BW

Great Britain

regulatory@flenhealth.com

Visit Website

Range of technologies

EU & UK Authorised Representative / Responsible Person

  • Medical Devices
  • Wound management
  • Barrier products

Any British citizen or another individual holding permanent-settled status in the UK and resident in Great Britain or legal entity incorporated in Great Britain employing a British citizen or another individual holding permanent-settled status in the UK and resident in Great Britain can apply for UKARA membership.

A range of membership types tailored specifically for you

View more benefits

View our latest news and updates

Toys (Safety) Regulations 2011: Great Britain
By Marcus Elliott August 24, 2022
Obligations of Authorised Representatives placing toys on the market in Great Britain
Personal Protective Equipment
By Mariana UKARA May 25, 2022
Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.
By Mariana UKARA February 2, 2022
Legislation applies from primary production to placing animal feed on the market and feeding of food producing animals.
UKCA mark
By Mariana UKARA November 24, 2021
In most cases, you must apply the UKCA marking to the product itself or to the packaging. In some cases, it may be placed on the manuals or on other supporting literature. This will vary depending on the specific regulations that apply to the product.
Making cosmetic products available to consumers in Great Britain
By Marcus Elliott November 4, 2021
The Responsible Person must make sure the cosmetic products they make available are safe. The Responsible Person should: know which ingredients are used in their cosmetic product, including those which are harmful or nanomaterials know about restrictions on what can be put in cosmetic products keep an up to date document with information on the cosmetic product (called the ‘Product Information File’ or ‘PIF’) make any information on the packaging, labelling and instructions for the cosmetic product clearly visible let the Office for Product Safety and Standards (OPSS) know about the cosmetic product (called notification) before it is made available to consumers tell OPSS about any serious harmful effects which are reported about the cosmetic product be able to prove that any claims made when marketing the product are correct
By Mariana UKARA October 20, 2021
The UK Competent Authority for medical devices, the MHRA, has advised that manufacturers not domiciled in the UK must appoint a formal UK Responsible Person (UKRP) or UK Authorised Representative (UKAR) to be able to continue placing medical devices on the UK market.
By Mariana UKARA September 16, 2021
You must include a business name and address on the packaging or food label of pre-packed food products. This must be either: the name of the business whose name the food is marketed under the address of the business that has imported the food Pre-packaged food or caseins sold in NI must include a NI or EU FBO address. If the FBO is not in NI or EU, include the address of your importer, based in NI or the EU. You can continue to use an EU, GB or NI address for the FBO on pre-packaged food or caseins sold in GB until 30 September 2022. From 1 October 2022, pre-packaged food or caseins sold in GB must include a UK address for the FBO. If the FBO is not in the UK, include the address of your importer, based in the UK. The address needs to be a physical address where your business can be contacted by mail. You cannot use an email address or phone number. https://www.gov.uk/guidance/food-labelling-giving-food-information-to-consumers#show-the-name-and-address-of-the-food-business-operator
By Marcus Elliott July 2, 2021
The UKCA is a certification mark that indicates conformity with the applicable requirements for products sold within Great Britain. The UKNI is Northern Ireland’s version of the UKCA mark. It is a new conformity marking for products place on the market in Northern Ireland which have undergone mandatory third-party conformity assessment by an approved body based in the UK. After June 2023, it will be mandatory to place a UKCA or UKNI on products being supplied into the UK. Whilst the UK continue to follow the current Medical Devices Directive, Northern Ireland with Europe now follow the upcoming MDR Medical Devices Regulation. Find out more on the government website: https://lnkd.in/dTE4VTs
By Marcus Elliott April 12, 2021
How do I know if my app is a medical device? If you are using an app for yourself or if you are using an app and you are not a trained healthcare professional, then this advice is for you. If the app you are using has a medical purpose it is important that it is UKCA or CE marked. There is a legal definition of a medical device but here are some practical examples; Depending on information you enter about yourself • Those which calculate medicine doses for you to take /inject • Those that tell you that you have a medical condition or disease or give you an individual percentage risk score of having one. Read more: https://www.gov.uk/government/publications/medical-devices-software-applications-apps
Overview of UK Responsible Person
By Marcus Elliott April 1, 2021
Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person must then register relevant devices with the MHRA in line with the above grace periods depending on the device class.
Show More
Share by: