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

Sell your product in the countries of the European Economic Area

Reduce the risk of customer dissatisfaction

Make Trading Easier

Improve Product Credibility

Ensure Product Safety

Increase Market size

Certified US UKCA Mark Certification Video

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.

Medical Devices



Measuring Instruments

Safety of Toys

Construction Products

Personal Protective Equipment


LED Lighting Products


Mobile Equipment


Wrist Watches / IVD Testing

Document required for UKCA Mark Certification

  • Technical File, Product Master File (TCF)
  • Product Testing
  • System Manual
  • System Procedure
  • Policy
  • Objectives
  • Mission & Vision
  • Plant Master File
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records

The extent of Documented Information differs as per:

  • Product and it's uses
  • Testing requirement of products
  • Directive in which product classified
  • Self Certification or Compliance Certification
  • Notify body Certificate

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:

Day 1

Scope defined,Self
Selection, Cost Estimates

• Finding standard applicable to the product
• Selecting the appropriate certification scheme
• Based on the scope of the product and certification scheme

Week 1

Developing Documents

• Technical file, Plant Master file and Test Protocol. Management System Manual, Management System Procedures, Policy, Objectives, Forms etc. Review of Standard Operating Procedures (SOP)

Week 4

Implementing Product Management System

• UKCA Mark Awareness training to QC manager and Production Manager. Implementing a well-documented manual throughout the life cycle of the product

Week 8

Internal Audit, MRM, CAPA

• Internal audits identifying nonconformities related to UKCA Mark requirements. Management Review Meetings. Corrective and Preventive Action plan for nonconformities

Week 10

Self Certification/NoBo/MHRA, Audit, N-C Closing

• Shamkris acts on your behalf and assists you in the third-party audit. Closing of any nonconformities identified by the Self Certification/NoBo/MHRA

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.

The UKCA marking applies to most goods previously subject to the CE marking. … In some cases, you need to apply the new UKCA marking to goods being sold in Great Britain immediately from 1 January 2021. The CE marking is only valid in Great Britain for areas where GB and EU rules remain the same.