Obligations of Authorised Representatives placing toys on the market in Great Britain

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

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.

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

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.

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

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

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

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.