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
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
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
Machinery
Lifts
Measuring Instruments
Safety of Toys
Construction Products
Personal Protective Equipment
Electronics
LED Lighting Products
Electrical
Mobile Equipment
Computers
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:
Time Frame
Task
Process
Day 1
Scope defined
Self Certification/NoBo/MHRA
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
Week 12
Self Certification/NoBo/MHRA
- UKCA Mark certificates issued for 5 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
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.