UKCAUnderstand and apply it correctly to your products

This market is now regulated by the UK, which has introduced its own regulatory system. It is called the United Kingdom Conformity Assessment or UKCA, and the primary legislation is "The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019".

• machinery
• low voltage electrical equipment
• measuring devices
• elevators
• radio equipment
• personal protective equipment
• toys
• recreational craft and personal watercraft
• non-automatic weighing instruments

• Medical devices and in-vitro diagnostics: Require registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA). Specific classifications for devices and diagnostics, based on risk, with specific requirements. Requires a UK-based representative with appropriate authorisation.
• Rail interoperability Specifications and rules governing operation and construction to ensure the safety of cross-border rail operations.
• Construction products The UK Construction Product Regulations establish certain standards and harmonised testing requirements for certain construction products. The regulations set out five different "systems" for manufacturers to comply with in order to obtain the UKCA mark for a product.
• Civilian explosives The UK has essentially adopted EU rules and requirements for civilian explosives. However, the main change is the requirement for a UK-registered representative with comprehensive powers, as well as the registration and authorisation of the product with the competent local authorities.

The importer must be a resident of the United Kingdom. Professional representatives established in the EU before 31 December 2020 will continue to be recognised, but newly established professional representatives must be established in the UK.

In the UK, what was previously referred to as a notified body is referred to as an authorised body and requires authorisation in the UK. Their function will be essentially the same: they will be commissioned by the importer or manufacturer to support and regulate the UKCA labeling process. Similarly, in the UK, "harmonised standards" are referred to as "designated standards". In many cases they remain very similar, but should be carefully checked for each product.

(EU companies importing products manufactured in the UK become "importers" in the EU and are subject to additional requirements).

The conformity assessment procedure for obtaining the authorisation to use the UKCA mark is very similar to the procedure used in the EU to obtain the CE mark. However, the details of the procedure differ for certain products and must be carefully examined.

A product may require either a self-assessment or the involvement of an approved body. The directive classifies products into different categories. These range from I to IV, according to the ascending order of the danger levels.

The use of an approved body is mandatory for products of category II or higher.

For Category II, III and IV products, the operating procedures and personnel shall be authorised by a competent third party in which the manufacturer, at the manufacturer's discretion, recognised itself as an authorised body or an authorised body by the UK supervisory authority third-party organization can act.

In order to grant such approvals, the approved body or third party shall have carried out or verified the tests and tests or equivalent tests and tests specified in the relevant notified standards.

Where deemed appropriate due to the risks of the product, the manufacturer should sample the product examine its characteristics and risks and, if necessary, maintain a list of complaints about non-compliant products and recalls of such products. The manufacturer shall inform the dealers of this monitoring.

The test programme shall be clearly defined before the test and accepted by the approved body responsible for the design conformity assessment module (if any). This programme shall lay down the test conditions and the criteria for acceptance or rejection. The actual values of the essential dimensions and characteristics of the materials that make up the tested product must be measured before testing. Where appropriate, the critical areas of the product must be observed during testing with appropriate equipment capable of detecting loads and stresses with sufficient accuracy.

The manufacturer shall provide the approved body with access to the manufacturing, acceptance, testing and storage facilities and provide it with all the necessary documentation, including the quality assurance system, technical documentation and quality reports such as test reports, test data, calibration data, reports on the qualifications of employees in this area, etc.

The accredited body shall conduct regular audits to ensure that the manufacturer maintains and applies the quality assurance system and shall provide it with an audit report. The minimum frequency of regular audits is a complete reassessment every three years.

In addition, the approved body may make unannounced visits to the manufacturer. The need and frequency of additional visits shall be determined on the basis of a visit control system operated by the approved body. The visit control system should take into account in particular the following factors: the product category, the results of previous monitoring visits, the need for corrective action, where appropriate, specific conditions relating to the approval of the system and significant changes in the organisation of production, production processes or methods. During these visits, the approved body may carry out product tests to verify the proper functioning of the quality assurance system. The accredited body shall provide the manufacturer with a report of the visit and, if tests have been carried out, a test report.

In general, they contain records of how the product was designed and manufactured, how it has been proven that the product meets the relevant requirements, as well as the addresses of the manufacturer and all storage facilities. These documents are essentially the same as those used for CE marking in the EU. However, a careful review of the UK requirements for each product should be made and additional documentation should be provided where possible. The documents shall be kept for at least ten years and shall be easily accessible at the request of an enforcement authority.

• the name and full business address of the manufacturer or representative authorised to issue the declaration in the UK
• a type of identification number, which can be the serial number, product or batch number, model or type,
• a statement stating that it is issued under the sole responsibility of the manufacturer
• a description of the product and the conformity assessment procedure used.
• a declaration that the declaration complies with the relevant legislation on designated standards
• references to the relevant designated standards used in or referred to in the technical specifications
• the name, address and identification number of the accredited body that carried out the conformity assessment procedure
• the identity and signature of the authorised person, and
• the date of issue of the declaration.

We at easyCE provide the instructions for explaining the specific product.

Pharmaceutical and life sciences products should be carefully considered as the UKFC regulations contain many specific requirements for them.

After all the necessary steps have been taken to ensure conformity, the UKCA mark should be applied to the product.

The minimum requirements for marking are: the letters remain proportional even when reduced or enlarged, they are at least 5 mm high and clearly visible, readable and indelible printed.

This is the standard format: