CE Marking

Technical file preparation and conformity assessment services for CE marking, mandatory for product entry into the EU market.

Standard
CE
Edition
Validity
2 years
Surveillance
No surveillance required

What is CE Marking?

CE marking is a mandatory conformity marking indicating that a product meets the essential requirements of EU directives. CE marking is mandatory for many products intended for export to the European Economic Area.

BESA Service Scope

  • Product classification and applicable directive identification
  • Risk assessment
  • Technical file preparation
  • Test planning and coordination
  • Declaration of conformity preparation

Certification Process

  1. 1 Product and regulatory analysis
  2. 2 Identification of applicable regulations and standards
  3. 3 Risk analysis and testing
  4. 4 Technical file preparation
  5. 5 Declaration of conformity and marking
  6. 6 Market surveillance and file updates

EU Regulations Covered

Machinery Directive 2006/42/AT
Low Voltage Directive 2014/35/AB
Electromagnetic Compatibility Directive 2014/30/AB
Radio Equipment Directive 2014/53/AB
Medical Devices Regulation 2017/745/AB
In Vitro Diagnostic Medical Devices Regulation 2017/746/AB
Personal Protective Equipment Regulation 2016/425/AB
Pressure Equipment Directive 2014/68/AB
Simple Pressure Vessels Directive 2014/29/AB
Toy Safety Directive 2009/48/AT
Construction Products Regulation 305/2011/AB
Recreational Craft Directive 2013/53/AB
Lifts Directive 2014/33/AB
ATEX Directive 2014/34/AB
Outdoor Noise Directive 2000/14/AT
Gas Appliances Regulation 2016/426/AB
Non-Automatic Weighing Instruments Directive 2014/31/AB
Measuring Instruments Directive 2014/32/AB
Explosives for Civil Uses Directive 2014/28/AB
Pyrotechnic Articles Directive 2013/29/AB
Marine Equipment Directive 2014/90/AB
Ecodesign Directive 2009/125/AT
Cableway Installations Regulation 2016/424/AB
Transportable Pressure Equipment Directive 2010/35/AB
RoHS - Restriction of Hazardous Substances 2011/65/AB
Railway System Interoperability Directive 2016/797/AB
Civil Firearms Regulation 2021/555/AB
Hot Water Boilers Efficiency Directive 92/42/AET
General Product Safety Regulation (GPSR) 2023/988/AB

The certificate is issued by an accredited certification body; BESA manages the process from application to certificate.