The technical requirements (“essential requirements”) of the UKCA marking, as well as the conformity assessment processes and standards that can be used to demonstrate conformity, are largely the same as they were for the CE marking. The circumstances in which the self-declaration of conformity can be used for UKCA marking are similar to those of the CE marking, such as for some Class I devices. Note that the CE marking is valid in Great Britain only for areas where GB and EU rules remain the same. Therefore, if the EU changes its rules and the product is CE marked based on those new rules, it will not be possible to use the CE marking to sell in Great Britain, even before December 31, 2022. However, in relation to medical devices, MHRA guidance on their regulation clearly states that the MHRA will continue to accept medical devices CE marked in conformance with the EU Medical Devices Regulation (2017/745) (MDR) or EU in vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) until June 30, 2023. This carve out will not only come as a relief for the industry but demonstrates the MHRA’s willingness to accommodate the medical devices business in the UK with the challenging realities of transitioning to parallel requirements under the EU and UK rules.
The new UKCA marking is required before January 1, 2023 only if the product (i) is for the market in Great Britain; (ii) is covered by legislation that requires the UKCA marking; (iii) and requires mandatory third-party conformity assessment and (iv) the conformity assessment has been carried out by a UK conformity assessment body. This requirement does not apply to existing stock, for example if the goods were fully manufactured, CE marked, and ready to be placed on the market before January 1, 2021. In these cases, the goods can still be sold in Great Britain with a CE marking even if covered by a certificate of conformity issued by a UK body before January 1, 2021. However, these goods will need to be placed on the market before December 31, 2022.
With regard to the UKCA marking itself, this must be clearly visible and legible when it is affixed to the product and must be placed on a product only by the manufacturer or its authorized representative (where permitted in the relevant legislation). Note that medical devices can have both marks present on the labeling prior to July 1, 2023, and that dual marking will continue to be accepted on the Great Britain market after July 1, 2023. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labeling where the UKCA mark has been affixed (including when devices have been dual marked).
When affixing the UKCA marking, the manufacturer takes full responsibility for the product’s conformity with the requirements of the relevant legislation. The UKCA marking must be used only to demonstrate conformity with the relevant UK legislation; its meaning or form must not be misconstrued to third parties, and no other markings may be attached on the product that affect the visibility, legibility, or meaning of the UKCA marking. The UKCA marking cannot be placed on products unless there is a specific requirement to do so in the legislation. There are specific rules on how to use the UKCA marking, including the general rules relating to its size, letters, and visibility. The UKCA marking can take different forms (e.g., the color does not have to be solid), as long as it remains visible and legible and maintains the required proportions.
The manufacturer or its authorized representative (where allowed for in the relevant legislation) must keep documentation to demonstrate that the product conforms with the regulatory requirements. This must be kept for up to 10 years after the product is placed on the market. Note that this information, which will vary depending on the specific legislation relevant to the product, can be requested at any time by market surveillance or enforcement authorities to check that the product conforms with the statutory requirements. General records of the following must be kept: how the product is designed and manufactured; how the product has been shown to conform to the relevant requirements; and the addresses of the manufacturer and any storage facilities. The information must be kept in the form of a technical file that can be supplied if requested by a market surveillance authority.
For most products lawfully bearing a UKCA marking, a UK Declaration of Conformity must be drawn up in which the manufacturer or, where applicable, the authorized representative states that the product conforms with the relevant statutory requirements applicable to the specific product. The MHRA recommends that manufacturers have two distinct ‘Declarations of Conformity’: one for the UK and one for the EU. The UK Declaration of Conformity should be available to market surveillance authorities on request. The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. The manufacturer will need to list the relevant UK legislation (rather than EU legislation) along with the relevant UK designated standards rather than standards cited in the Official Journal of the European Union.
The MHRA guidance provides further information on product areas covered by the UKCA marking and on legislative areas where self-declaration of conformity for UKCA marking is permitted.