The United Kingdom Conformity Assessment Mark or UKCA Mark for short is the UK equivalent of the EU CE marking. UKCA Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United Kingdom Conformity Assessment (UKCA) marking is mandatory for medical devices sold on the market in Great Britain (England, Wales, and Scotland).United Kingdom’s Medicines and Health Care products Regulatory Agency (MHRA) On 18 September 2019, published new guidelines to regulate medical devices after Brexit. The UKCA will not be recognized in the EU, EEA, or Northern Ireland and products still require a CE marking for sale in these markets.The manufacturer or their authorized representative will be responsible for affixing the UKCA mark to the product, which is the same principle as for CE marking but for the UK market.Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain a certificate of success in addition to enhanced performance. Our certification services empower businesses to achieve their goals through expert guidance, establishment consultancy, implementation, and training, ensuring alignment with both government and private certification bodies. With a global vision and a local focus, Shamkris Global Group is dedicated to supporting your business in successfully navigating the complex regulatory and certification landscapes.Who Needs UKCA Mark Certification? Manufacturers of Electrical and Electronic ProductsConsumer Goods Manufacturers and DistributorsIndustrial Machinery and Equipment ProducersConstruction and Building Material SuppliersAutomotive Parts and Accessories ProducersMedical Device and Healthcare Equipment ManufacturersPersonal Protective Equipment (PPE) SuppliersExporters of Goods to the UK MarketRetailers and Wholesalers of UK Imported Goods
