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Overview of UK Responsible Person
UK Responsible Person
To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person
that is established in the UK. Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. Importers and distributors are not required to appoint a UK Responsible Person.
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.
The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 (as amended). In summary, in addition to the above registration requirements, the UK Responsible Person must:
- ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
- keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
- in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
- where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
- where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
- immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
- if the manufacturer acts contrary to its obligations under these Regulations:
- terminate the legal relationship with the manufacturer; and
- inform the MHRA and, if applicable, the relevant Approved Body of that termination.
It is possible for an importer or distributor to act as a UK Responsible Person.
The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices.
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.
Legislation applies from primary production to placing animal feed on the market and feeding of food producing animals.
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
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.
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