Blog Layout

Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018: Great Britain

Authorised representatives obligations for Personal Protective Equipment (PPE)


Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.


Mandated authorised representatives for the GB market can be based in GB or Northern Ireland, but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the Regulations as they apply in GB.


No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for PPE being placed on the Northern Ireland and EEA markets. Therefore, a GB manufacturer selling PPE to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of that PPE, must appoint an authorised representative based in Northern Ireland or the EEA.


The mandate shall at least allow the authorised representative to perform the following tasks:


  • keeping the declaration of conformity and the technical documentation at the disposal of the market surveillance authority in the UK for 10 years after the PPE has been placed on the GB market
  • further to a reasoned request from the enforcement authority in the UK, providing that authority with all the information and documentation necessary to demonstrate the conformity of the PPE
  • cooperating with the enforcement authority in the UK, at its request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative’s mandate


An authorised representative must comply with all the duties, imposed on the manufacturer under the 2016 Regulation, that they are appointed for and mandated by the manufacturer to perform. A manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf and an authorised representative is under a duty to perform those tasks, and any failure to do so may make the authorised representatives liable to penalties.


Read more:

Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018: Great Britain - GOV.UK (www.gov.uk)


UK Authorised Representatives interested in joining the Association should contact UKARA by email enquiries@ukara.org or apply via https://ukara.org.


Toys (Safety) Regulations 2011: Great Britain

Statutory guidance: Toys (Safety) Regulations 2011: Great Britain

By Marcus Elliott • 24 Aug, 2022
Obligations of Authorised Representatives placing toys on the market in Great Britain

Importing or moving animal feed into GB from the EU and non-EU countries

By Mariana UKARA • 02 Feb, 2022
Legislation applies from primary production to placing animal feed on the market and feeding of food producing animals.
UKCA mark

Using the UKCA mark

By Mariana UKARA • 24 Nov, 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

Making cosmetic products available to consumers in Great Britain

By Marcus Elliott • 04 Nov, 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

New standard on Management System specifications published by UK Authorised Representative Association UKARA

By Mariana UKARA • 20 Oct, 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.

Food labelling: giving food information to consumers

By Mariana UKARA • 16 Sep, 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

UKCA marking

By Marcus Elliott • 02 Jul, 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

Medical devices: software applications (apps)

By Marcus Elliott • 12 Apr, 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

Overview of UK Responsible Person

By Marcus Elliott • 01 Apr, 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.
Regulations: noise emissions from outdoor equipment

Regulations: noise emissions from outdoor equipment

By Marcus Elliott • 14 Jun, 2020
From 1 January 2021 there are some differences in the rules for placing outdoor machinery on the market in Great Britain (England, Scotland and Wales) and placing outdoor machinery on the market in Northern Ireland.
More Posts
Share by: