Client: Dermaco Ltd
Dermaco Ltd. has been providing for the needs of Laboratories, Hospitals and Pharmaceutical Companies since 1981. Dermapak ® has been used extensively in the U.K and internationally for over 35 years for routine diagnostic work and for clinical trials. It is employed as the system of choice by Medical, Pharmaceutical and other establishments, and is recommended by a number of eminent specialists in mycology.
One of the consequences of leaving the EU is that products manufactured and sold in the UK can no longer use CE marking to indicate that they comply with the relevant quality standards. From January 1st 2023 British goods must carry the UKCA mark. If the products are to be sold in the EU they must carry the CE mark as well. This requires that a company in the EU, designated the Responsible Person, guarantees the that the products meet EU quality regulations and is responsible for product recalls etc. if necessary. As such it is not something to be entered in to lightly and should be done by a company that has a comprehensive understanding of the product. Whilst Dermaco has agents in the USA and Switzerland, the preferred method of sale to customers in the EU is direct. As such, there was no obvious candidate, such as a European distributor, to take on the role of Responsible Person for Dermaco.
Dermaco was aware of the need to get organised ready for the changes to CE / UKCA marking but didn’t fully understand their obligations or how to go about finding a suitable representative in the EU. After consulting with their local Chamber of Commerce, they handed the whole issue over to The International Trade Consultancy.
Our research revealed that as Dermaco previously did a self-declaration of conformance for the CE mark they were allowed do a self-declaration for the UKCA mark. A detailed technical file is required as supporting evidence and although the UKCA mark is required on goods from 01/01/2023, an overlaid label will be accepted until 01/01/2024. It was also permissible for Dermaco to do a self-declaration for the CE mark. The Responsible Person needs a written mandate from the manufacturer and also copies of the technical file and the self-declaration of conformance as they will be responsible for any quality issues arising in connection with the products. The Responsible Person’s contact details should be included on the product if possible and also the packaging of all goods sold to the EU. As with the UKCA mark, the CE mark needs to be on products and packaging from 01/01/2023.
Having explained the obligations associated with complying with the new CE / UKCA marking rules, The International Trade Consultancy was able to put Dermaco in touch with three companies who were qualified to act as their Responsible Person in the EU.