- Need Consultation?
CE & UKCA Compliance – Ensure Your Product Meets Regulatory Standards
Ensure Compliance, Simplify Certification, and Safeguard Your Market Access
Our Services
We provide comprehensive compliance solutions tailored to your business needs.
CE & UKCA Marking Support
We guide you through the CE and UKCA marking processes, ensuring your products meet EU and UK regulatory standards.
Learn MoreProduct Safety Compliance
Ensure your products meet global safety standards with our risk assessments, testing, and compliance documentation services.
Learn MoreTesting & Certification Coordination
We coordinate testing and certification processes to ensure your products meet all regulatory requirements.
Learn MoreRegulatory Consultancy
Get expert advice on regulatory compliance, market access, and risk management tailored to your business.
Learn MoreEnvironmental & Sustainability Compliance
We help you meet environmental regulations and integrate sustainable practices into your business operations.
Learn MoreAuthorised Representative Services
Act as your EU/UK representative, ensuring compliance with regulatory requirements and market surveillance.
Learn More
CE Marking
What is CE Marking?
- CE Marking is a mandatory conformity mark for products sold within the European Economic Area (EEA).
- It signifies that a product meets EU safety, health, and environmental protection standards.
- CE Marking allows free trade across EU member states.
Products Requiring CE Marking
- Electrical and electronic devices
- Machinery
- Toys
- And many more
How to Obtain CE Marking
-
Identify Applicable Directives and Regulations
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- EMC Directive (2014/30/EU)
-
Conduct a Conformity Assessment
- Internal design and risk assessments
- Product testing according to EN standards
-
Involvement of a Notified Body (If Required)
- Required for high-risk products like medical devices.
-
Compile Technical Documentation
- Product design specifications
- Risk assessment reports
- Test reports and compliance certificates
- User manuals and safety instructions
- Declaration of Conformity (DoC)
-
Affix the CE Mark
- Must be visible, permanent, and at least 5 mm in height.
Why CE Marking is Important
- Legal Market Access
- Consumer Trust & Safety
- Avoids Market Barriers
- Prevents Penalties & Recalls
How We Can Help
- Identify applicable EU directives and standards
- Conduct risk assessments and compliance checks
- Coordinate with Notified Bodies
- Prepare technical documentation and Declarations of Conformity
- Provide expert guidance on product labeling
UKCA Marking
What is UKCA Marking?
- UKCA Marking is the UK’s product compliance marking, replacing CE Marking for most goods in Great Britain (England, Scotland, Wales).
- Applies to products like:
- Electrical devices
- Machinery
- Toys
How to Obtain UKCA Marking
-
Identify Applicable UK Regulations
- Supply of Machinery (Safety) Regulations 2008
- Electrical Equipment (Safety) Regulations 2016
- Electromagnetic Compatibility Regulations 2016
-
Conduct a Conformity Assessment
- Risk assessments and safety evaluations
- Product testing based on UK standards
-
Involvement of a UK-Approved Body (If Required)
- Required for high-risk products like medical devices.
-
Compile Technical Documentation
- Product design specifications
- Risk assessment reports
- Test results and compliance certificates
- User manuals and safety instructions
- UK Declaration of Conformity (DoC)
-
Affix the UKCA Mark
- Must be visible, permanent, and at least 5 mm in height.
Why UKCA Marking is Important
-
✅ Legal Market Access
✅ Consumer Trust & Safety
✅ Avoids Market Restrictions
✅ Prevents Fines & Product Recalls
How We Can Help
-
✔ Identify applicable UK regulations and standards
✔ Conduct risk assessments and compliance checks
✔ Coordinate with UK-Approved Bodies
✔ Prepare technical documentation and UK Declarations of Conformity
✔ Provide expert guidance on UK product labeling
Ensuring Product Safety & Regulatory Compliance
What is a Risk Assessment?
- A structured process to evaluate potential hazards and ensure compliance with safety standards.
- Mandatory under key directives like:
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- EMC Directive (2014/30/EU)
- General Product Safety Regulation (GPSR)
Risk Assessment Process
-
Hazard Identification
- Identify mechanical, electrical, thermal, chemical, ergonomic, and environmental risks.
-
Risk Analysis
- Evaluate likelihood and severity of each risk.
-
Documentation & Compliance Reporting
- Compile a Risk Assessment Report for inclusion in the Technical File.
Why is Risk Assessment Important?
- ✔ Regulatory Requirement
- ✔ Prevents Product Recalls & Legal Issues
- ✔ Protects Users & Brand Reputation
- ✔ Improves Market Access
Our Risk Assessment Services
- ✔ Machinery & Industrial Equipment
- ✔ Electrical & Electronic Devices
- ✔ Consumer Products & IoT Devices
Technical Documentation
What is Technical Documentation?
- A collection of documents proving a product meets safety, health, and environmental standards.
- Includes:
- Design & Manufacturing Information
- Risk Assessments & Safety Evaluations
- Test Reports & Results
- Declaration of Conformity (DoC)
- Assembly & Operating Instructions
- Marking & Labeling Information
Why is Technical Documentation Important?
- ✔ Regulatory Requirement
- ✔ Compliance Proof
- ✔ Market Surveillance & Inspections
- ✔ Product Safety & Liability
- ✔ Smooth Certification & Market Access
Key Directives Requiring Technical Documentation
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- EMC Directive (2014/30/EU)
- Radio Equipment Directive (RED) (2014/53/EU)
- RoHS Directive (2011/65/EU)
Our Technical Documentation Services
- ✔ Technical File Creation
- ✔ Risk Assessment & Safety Documentation
- ✔ Declaration of Conformity (DoC)
- ✔ Marking & Labeling Compliance
- ✔ Product Testing & Certification Coordination
- ✔ Ongoing Technical File Updates
Why Choose Us?
Expert Knowledge
Expert knowledge of compliance requirements to ensure your products meet all regulations.
Streamlined Process
Streamlined and efficient process to save you time and resources.
Regulatory Expertise
In-depth understanding of EU & UK regulations for seamless compliance.
Risk Management
Comprehensive risk management to protect your business and customers.