UKCA MARK CERTIFICATION
What is UKCA Mark Certification?
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.
Benefits of UKCA Mark Certification
Who can be certified UKCA Mark Certification?
Most products that are currently covered under regulations and directives for CE marking will fall under the scope of UKCA marking.
Safety of Toys
Personal Protective Equipment
LED Lighting Products
Document required for UKCA Mark Certification
The extent of Documented Information differs as per:
Role of Shamkris and Process of UKCA Mark Certification
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Implementing Product Management System
Year on Year
UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.