OnRule publications - Series 2

Publications

Series 2
  1. Saudi Arabia's Supplier Declaration of Conformity (SDoC) for Restriction of Hazardous Substances (RoHS)
  2. Australia Supplier's Declaration of Conformity (SDoC) & Regulatory Compliance Mark (RCM)
  3. Cybersecurity and Product Regulatory Compliance: Part 2
  4. Cybersecurity and Product Regulatory Compliance: Part 1
  5. Product Regulatory Compliance: Compliance Model Number and Product Tree
  6. Product Regulatory Compliance: UK Declaration of Conformity (DoC) & UKCA Marking
Special topic for Product Regulatory Compliance

UK Declaration of Conformity (DoC) & UKCA Marking

By Tom Killam and Cyril Mecwan

March 18, 2022 | Series 2 / No. 1 | V3.0

Starting January 1st, 2023, where applicable, the United Kingdom (UK) will require businesses to place UKCA Marking on the product and issue self-declaration, called “UK Declaration of Conformity” (UK DoC), while placing manufactured goods to the UK market.

The differences and similarities in requirements between the UK DoC and EU DoC, and the difference between the United Kingdom (UK) and Great Britain (GB) etc. are creating ambiguity. This special editorial is aimed at bringing much-needed clarification to the requirements of the UK DoC and UKCA Marking.

This topic has many details, and this summary may not be able to ‘catch all’. Nonetheless, our effort is to present the requirements in an easy to understand editorial.

Background:

Post-Brexit, starting January 1st, 2023, the United Kingdom requires the manufacturer placing goods on the market in the UK to apply UKCA Marking and issue a self-declaration (where applicable), known as UK Declaration of Conformity.

It is important to understand that the Great Britain (GB) encompasses England, Wales and Scotland, whereas the United Kingdom (UK) also encompasses Northern Ireland (NI) in addition to England, Wales and Scotland.

The Great Britain (GB) requirements:

Here, we are discussing the UK DoC whose applicability is limited to GB. The requirements are different for NI.

A. The DoC requirements for GB:

The UK DoC has many similarities with that of the EU DoC. Most of the manufactured products, subject to UKCA marking, will be accepted with the CE mark in the UK only until 31st December, 2022.

Note that the medical devices will be allowed in the UK market with the CE mark until 30th June, 2023.

Medical devices, civil explosives, construction products, rail interoperability, cosmetics, tobacco, fertilisers, products requiring ecodesign and energy labeling, chemical, medicines, veterinary medicines, vehicles, aerospace have special rules.1,2

The following key content is required while creating the UK DoC:

  • The title of the DoC: The title of the document should be ‘UK Declaration of Conformity’.
  • The issuer of the DoC: The manufacturer or the Authorized Representative of the manufacturer located in the UK may draw up and authorize (sign) the UK DoC.
    The term ‘manufacturer’ is synonymous with the term ‘Original Equipment Manufacturer’ (or OEM), who owns the brand. It does not mean the factory where the product is manufactured or assembled.
  • Address: The manufacturer’s name and full business address are displayed on the DoC. If the manufacturer is a ‘Responsible Person’, then it can be located anywhere in the world. However, some UK legislation requires the ‘Responsible Person’ to be established in the UK (for example, the medical devices). In this case, if the manufacturer is the ‘Responsible Person’, it must have a UK based address.

    Additionally and importantly, if the ‘Responsible Person’ is a third-party ‘Authorized Representative’ (AR) representing the manufacturer in GB, the UK DoC requires the name and address of the manufacturer’s Authorized Representative (person or the entity) who is required to be established in the UK (must reside in the UK).

    In the event the manufacturer is located in the UK, the business and the Authorized Representative can be the same entity.

  • Product related information: Provide the product identification information including product model (the product’s serial number, model or type identification) that appears on the regulatory compliance document for this product.
  • Declaration statement: The issuer of the DoC must declare that the product is in conformity with the relevant statutory requirements applicable to the specific product, and that the issuer takes full responsibility for the product’s compliance.
  • Legislation: The UK DoC must list all relevant regulations that apply to the manufacturer’s product. For the typically used EU Directives, there are respective UK Regulations in place3 – the latest update was issued on February 16, 2022. However, considering there is a large number of EU Directives and legislations already in place, it will obviously take some time to create a 1:1 mapping of the equivalent UK legislation.

    For an easy explanation and comparison, below is an example of the corresponding laws for Safety and EMC for both markets:
    Safety:
    • EU: 2014/35/EU LVD Low Voltage Directive
    • UK: Electrical Equipment (Safety) Regulations 2016

    EMC:
    • EU: Electromagnetic Compatibility (EMC) Directive 2014/30/EU
    • UK: Electromagnetic Compatibility Regulations 2016

Note that the EU uses the word ‘Directive’ for the regulatory legislation, whereas the UK uses the word ‘Regulation’.

Unlike the Safety, EMC, Radio and RoHS legislations, the legal requirements to place a medical device product in the UK market is managed by the Medicines and Healthcare products Regulatory Agency (MHRA).

  • Technical Standards: The UK has published a list of UK designated standards that businesses can use to show their products, services or processes comply with essential requirements of legislation. This list is updated regularly, and therefore, the user should check for the updates for her/his applicable regulations.4

    While creating the UK DoC, the Compliance professional must ensure that the technical standards on the DoC are present in the lists of UK designated standards that can be used to demonstrate the presumption of conformity in the UK.

    Although UK’s legal requirements for the designated standards may change in the future to include the standards designated by UK’s National Standards Body, British Standards Institution (BSI), today, ‘All harmonised standards that give presumption of conformity with EU law became designated standards, which businesses can use to provide presumption of conformity with GB law’.5 Generally, we have observed that the lists of UK designated standards match with the lists of harmonised standards in the EU. Because the EU observes the EN standards published either from CEN, CENELEC, or ETSI OR the international standards ISO, IEC, or ITU – and because both the EU and UK are members of these organizations, today, the UK Regulations have accepted these standards ‘as is’.

    Although placing UK’s national prefix ‘BS’ in front of the designated EN standards is an accepted nomenclature, it is NOT a mandate by the UK. A manufacturer may use the ‘EN’ prefix ‘as is’, without having to use the prefix ‘BS’ in front of the designated standards. Below is an example of accepted nomenclature of the designated standards:
  • EN 62368-1:2014
  • BS EN 62368-1:2014
  • EN IEC 63000:2018
  • BS EN IEC 63000:2018

Today, our recommendation is to use only the ‘EN’ prefix, which will allow the businesses to maintain simplicity by keeping track of only the EN standards.

The legislations and technical standards for many regulations, including, but not limited to, Product Safety, EMC, Radio, etc. are covered by the Office for Product Safety and Standards (OPSS).

The legislations and designated standards for the medical devices are managed by the MHRA.6

  • Approved Body: For the following legislation, ALL products can be self-declared without the need for an Approved Body:
  • Electromagnetic Compatibility Regulations 2016
  • The Electrical Equipment (Safety) Regulations 2016
  • The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

For other legislations, restrictions apply, where the conformity assessment must follow Type-examination for certain categories or instances. For example,

  • Radio Equipment Regulations 2017
  • Medical Devices Regulations 2002
  • Toy (Safety) Regulations 2011
  • The Supply of Machinery (Safety) Regulations 2008

Note that for the most cases, the Radio Equipment Regulations 2017 will allow a self-declaration.

Please refer to the government website to find the relevant details for your applicable legislation. 7,8

UK Approved, UK based bodies (must be independent of the manufacturer) are the Conformity Assessment Bodies (CAB), which are authorized to carry out the procedure for conformity assessment and certification for the GB market. Upon successful conformity assessment, they will issue the Certificate of Conformity. Through Mutual Recognition Agreements (MRA), the UK is also designating Approved Bodies in other countries.

The following information related to the Approved body is required on the UK DoC when an Approved body is involved in the Type-examination:

  • Name of the Approved body
  • Identification number of the Approved body
  • Number of the Type-examination Certificate
  • Issue date of the Certificate
  • Your Name and Signature
  • The Date the Declaration was Issued
  • Supplementary Information (if applicable): This field is to provide any supplementary information that you feel should be included in the DoC.
B. Record Keeping:

The manufacturer or the Authorized Representative is required to keep the documents (to demonstrate that the product conforms with the regulatory requirements) for up to ten years after the product is placed on the market. In addition to the DoC, we recommend that at the least the supporting test reports, product label showing the UKCA marking, and Type-certification from an Approved body (if applicable), must be available on-demand. The market surveillance authority of the UK reserves the right to review the documentation that can demonstrate that your product conforms with the regulatory requirements.

C. UKCA marking:

Most of the product areas are covered by and require the UKCA marking. Although there are exception and special rules, in general, most of the manufactured products shipped to Great Britain on or after January 1st, 2023 will require the UKCA marking. The UKCA marking apply to medical devices, civil explosives, construction products, and rail interoperability, too, however, they have special rules.

  • Size of the UKCA mark: The UKCA marking is at least 5mm in height. If you make any changes to the size, the letters forming the UKCA marking must be in proportion to the version shown on the government website for the UKCA.  You can obtain the UKCA mark details here.9
  • Placement of the UKCA mark: The UK DoC does not stipulate that the UKCA marking be placed on the DoC itself.

    The UKCA marking will be applied to the product such that it is visible and legible. If this is not possible, alternatively, it can also be placed on the packaging. In some instance, it may be placed in the manual or supporting literature.

Reference: