Responsibilities and Mandate of an EU Authorised Representative

What is UKCA marking?

The UKCA marking is a new UK product conformity marking that is mandatory for different types of goods placed on the market in Great Britain. It covers most goods which previously had to be CE marked – for example, medical devices, electrical equipment, toys, aerosols, machinery, etc. The UKCA marking officially came into effect in January 2021. However, businesses were given time until the end of December 2022 to adjust to the new product safety requirements. Until then, CE marking is still valid in the UK.

The goods that are required to have the new UKCA mark affixed on their surface or packaging are any that fulfil the following conditions:

·The product is placed for sale on the GB market
·UKCA marking is required
·The product requires a third-party conformity assessment
·The conformity assessment has been or will be carried out by a UK assessment body (UK database).

Special conditions for Northern Ireland businesses

Northern Ireland companies will still be able to place qualifying Northern Ireland goods bearing only the CE marking on the market in Great Britain after December 2022 if any of the following conditions apply:

·the CE marking is currently used for the product on the basis of self-declaration
·any mandatory third-party assessments were performed by an EU-recognised notified body
·a UK-based body carried out any obligatory third-party conformity assessments; therefore, the product has both the CE marking and the new UKNI marking.

What is CE marking?

CE marking is a product conformity marking that proves the compliance of a number of goods with the European health, safety & environmental protection legislation. Goods that bear the CE marking symbol on their surface or packaging are allowed for sale on the EU single market and the market in some other countries, such as Turkey and Switzerland.

What goods need the UKCA marking?

Similarly to CE marking, the UKCA mark is not mandatory for all products entering the GB market. Examples of goods that fall within the scope of the new product conformity marking are as follows:

·Rail products
·Medical devices
·Construction products
·Toys
·Electrical equipment and electronics
·Marine equipment
·Pressure equipment
·Lifts
·Non-automatic weighing instruments
·Recreational craft
·Machinery, and more.
·Goods such as makeup, pharmaceuticals, food and books do not fall within the scope of the UKCA marking.

What is the certification process for obtaining UKCA or CE marking?

To obtain either or both product conformity markings, businesses will need to undertake the following certification steps:

·Identify all relevant UK or EU directives and standards
·Verify the specific requirements that the product must fulfil
·Identify whether or not an independent third-party conformity assessment is required
·Perform product conformity testing
·Compile technical documentation
·Draw up a Declaration of Conformity
·Affix the respective conformity marking (UKCA or CE) to the product’s surface and/or packaging
·Register the product with the national market authorities.

The UKCA technical documentation requirements businesses must meet – and the conformity assessment processes and product safety standards that can be used to prove conformity – are largely the same as those for the CE marking.

Furthermore, the circumstances in which companies can use self-declaration of conformity for UKCA marking are the same as those for CE marking. For instance, category I personal protective equipment, some class I medical devices, category I pressure equipment, and construction products within the scope of system 4 can have self-declaration of conformity. More information on UKCA self-declaration of conformity.

What are the UKCA directives & regulations?

Businesses wanting to sell products in the UK covered by the UKCA legislation will need to identify what safety requirements their goods must fulfil. In this regard, they will need to determine if one or several of the below listed UK directives and regulations apply to their products.

UKCA directives & regulations:

·Toys (Safety) Regulations 2011
·Simple Pressure Vessels (Safety) Regulations 2016
·Recreational Craft Regulations 2017
·Electromagnetic Compatibility Regulations 2016
·Non-automatic Weighing Instruments Regulations 2016
·Electrical Equipment (Safety) Regulations 2016
·Measuring Instruments Regulations 2016
·Equipment & Protective Systems for Use in Possibly Explosive Atmospheres Regulations 2016
·Lifts Regulations 2016
·Pressure Equipment (Safety) Regulations 2016
·Regulation 2016/426 on gas appliances as brought into UK law and amended
·Regulation 2016/425 on personal protective equipment as brought into UK law and amended
·Supply of Machinery (Safety) Regulations 2008
·The Ecodesign for Energy-Related Products Regulations 2010
·Noise Emission in the Environment by Equipment for Use Outdoors Regulations 2001
·Energy Labelling Regulation (EU) 2017/1369 (as retained in UK law and amended)
·The Pyrotechnic Articles (Safety) Regulations 2015
·Restriction of the Use of Specific Hazardous Substances in EEE Regulations 2012.

Regarding medical devices, rail interoperability, civil explosives and construction products, manufacturers will need to refer to special guidance documents.

What are the requirements for the UKCA technical documentation?

The technical documentation must demonstrate the product’s compliance with the relevant UK statutory requirements. It must also be kept for up to 10 years after the product is placed on the market. Manufacturers must ensure that the technical documentation is always available and can be instantly provided to the market surveillance authorities upon request.

The contents of the technical documentation vary depending on the specific directive or regulation relevant to each product. However, manufacturers must keep general records of:

·how the product is designed and produced
·how the product has fulfilled the applicable legal requirements
·their business address and the addresses of any storage facilities.

What are the rules for the UKCA Declaration of Conformity?

The UK Declaration is a document manufacturers must draw up for any products lawfully bearing a UKCA marking. The contents of the UK Declaration of Conformity are essentially the same as those of the EU Declaration. Because of that, it is recommended that products sold on both EU and UK markets have two separate Declarations – one for CE marking and another for UKCA marking.

In the UK document, the manufacturer should:

·declare that the product fulfils all relevant UK statutory requirements
·specify their name and complete business address or that of their authorised representative
·specify the product’s model, serial number or type identification
·include a statement stating that they take full responsibility for the product’s compliance
·provide the details of the UK assessment body which performed the conformity assessment procedure (where applicable)
·list all relevant legislation (directives and standards) with which the specific product complies
·provide their name and signature
·state the date the UK declaration was issued
·include any supplementary information such as product photos (if applicable).

The UK Declaration should be provided to the market surveillance authorities upon request. The same is valid for the EU Declaration of Conformity.

How to affix the UKCA or CE marking to a product?

The rules for affixing UKCA or CE marking to a product are the same. In most cases, businesses must apply the UKCA or CE marking to the product’s surface or packaging. In rare cases, the mark may be placed on the user manuals or other product documentation. The directives that apply to the product specify the exact rules for affixing the appropriate marking.

In general, the following rules apply:

·The UKCA or CE marking must be visible and legible when affixed to the product. If the latter is impossible, the conformity marking must be attached to the product’s packaging (if any) or accompanying documents.
·The UKCA marking must only be placed on a product by the manufacturer or their UK authorised representative (if permitted in the relevant UK legislation).
·CE marking is only used to demonstrate conformity with relevant EU legislation, and UKCA marking is only used to prove conformity with relevant UK legislation.
·The attachment of any markings or signs that may lead to the misinterpretation of the meaning or form of the UKCA or CE marking is forbidden.
·If other markings or signs are affixed to the product’s surface, packaging or accompanying documentation, the visibility, legibility and meaning of the respective conformity marking (UKCA or CE) must not be affected.
·In size, UKCA and CE must be at least 5 mm high (unless relevant legislation doesn’t specify a different minimum dimension)
·The proportions of the letters forming each marking must always be respected, even if the size of the marking is reduced or enlarged.

In addition, the UKCA marking can take different forms as long as the above rules are respected. For instance, the colour does not have to be solid.

Who is responsible for acquiring CE & UKCA marking?

Generally speaking, the primary responsible party for acquiring CE or UKCA certification is the product’s manufacturer. However, this is valid only if the manufacturer is located in the EU or the UK and sells their products under their brand name. If products are produced overseas, then the responsibility for ensuring products’ UKCA or CE compliance falls on the importer.

A manufacturer’s responsibilities

A manufacturer is a business responsible for designing and producing a product with the goal of selling it on the market under its own brand name.

Regarding CE and UKCA markings, the manufacturer must ensure that their products’ design and production are in accordance with all relevant legislation. The manufacturer is also responsible for the following:

·Assemble technical documentation
·Ensure that any required conformity assessment procedures are carried out
·Draw up a Declaration of Conformity (for construction products, a Declaration of Performance)
·Affix the appropriate conformity marking (UKCA or CE) to the product’s surface, packaging, or accompanying documentation.

In addition to the stated above, the manufacturer must also:

·Maintain records of any conformity-related documentation
·Ensure that suitable quality control procedures are in place so series productions remain in conformity
·Ensure that products bear identification marking such as a type, batch or serial number
·Indicate their business information (e.g. name, address, registered trade name) on the product’s surface, packaging or a document accompanying the product.
·Ensure that each product comes with IFU (instructions for use) and other related safety information in a language that end-users can understand.
·Provide market authorities with information and documentation demonstrating a product’s compliance with all relevant legislation.
·Take appropriate actions if a product’s conformity status is questioned.

An importer’s responsibilities

In cases of products manufactured overseas, importers must ensure the products’ compliance with all relevant legislation before placing them on the market. In some cases, this would mean that importers must perform necessary conformity testing or validate the completeness of the technical documentation.

A seller’s responsibilities

Sellers must ensure that all goods they sell to consumers have appropriate UKCA or CE marking. Otherwise, they risk receiving a fine for supplying non-compliant goods.

What are the special rules for medical devices concerning UKCA marking?

Businesses wanting to place medical devices, including IVDs, systems or procedure packs and custom-made devices, must take into consideration the following changes:

·All devices have to be registered with the MHRA before they’re placed on the GB market
·Appoint a single UK Responsible Person for all of their medical devices if their place of business is located outside the UK
·Certificates issued by EU Notified Bodies will continue to be valid for the UK market until 30 June 2023
·UK Notified Bodies can no longer issue CE certificates
·In the UK, medical devices must comply with the requirements of the Medical Devices Regulations 2002
·Self-declaration of conformity with the UK legislation is possible for non-sterile Class I devices, non-measuring Class I devices and general IVDs.
·Devices with a valid CE marking don’t need to be re-labelled with a UKCA marking until 30 June 2023.
·Devices can have both the UKCA and CE markings on the labelling before 1 July 2023; dual marking will still be accepted on the GB market after 1 July 2023.
·Manufacturers must submit vigilance reports to the MHRA when incidents involving their devices occur in the UK
·Ensure that products fulfil appropriate safety and performance standards for as long as they are in use.

What are the legal responsibilities of the UK Responsible Person?

The UK Responsible Person must have written evidence that the manufacturer authorises them to act as their UK Responsible Person. An importer or distributor located in the UK can also act as a UK Responsible Person.

The UK Responsible Person can carry out specific tasks in relation to the manufacturer’s responsibilities. These tasks are set out in the UK MDR 2002 and include, among many:

·registering the medical devices with the MHRA
·ensure that the technical documentation and UK declaration of conformity have been drawn up
·ensure that the manufacturer has performed any required conformity assessment procedures
·keep available a copy of all product compliance documents
·collaborate with the MHRA and provide the authorities with all the information and documentation necessary to validate the conformity status of a device
·inform the manufacturer about any complaints and reports from healthcare specialists, patients and users
·report to the UK authorities if the manufacturer acts contrary to their obligations under the UK MDR 2002.

The business name and address of the UK Responsible Person must be present on the product’s label or its outer packaging or in the instructions for use. The contact details of the UK Responsible Person do not need to be part of the labelling for CE-marked medical devices unless they bear both the UKCA and CE markings. Read here about the responsibilities of the EU-authorised representative.

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