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 IANZ is the New Zealand Designating Authority for CE Marking for testing and calibration laboratories and inspection bodies under a New Zealand Government Agreement with the European Union.

CE (European Conformity) marking is generally required for products being traded within Europe. Essentially, the mark indicates that a product conforms to the provisions of safety, public health and consumer protection requirements imposed by European Directives.

The CE Mark is a safety rather than a quality mark and is a mandatory requirement for the following types of products:

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  • Low Voltage
  • Simple Pressure Vessels
  • Safety of toys
  • Construction products
  • Electromagnetic compatibility (EMC)
  • Machinery
  • Personal protective equipment (PPE)
  • Non-automatic weighing instruments
  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels
  • Explosives for civil uses
  • Medical devices
  • Equipment explosive atmospheres (ATEX)
  • Recreational craft
  • Lifts
  • Pressure equipment
  • In vitro diagnostic medical devices
  • Radio Equipment and Telecommunications Terminal Equipment
  • Cableway installations designed to carry persons
  • Measuring instruments

Although there are 21 directives, only 6 of the directives have been included in the NZ-EU Agreement. These are:
  • Low Voltage
  • Simple Pressure Vessels
  • Electromagnetic compatibility (EMC)
  • Machinery
  • Medical devices
  • Radio Equipment and Telecommunications Terminal Equipment

Currently, of the above 6 directives, 2 directives can be applied through IANZ designated facilities in New Zealand. These are:

  • Low Voltage directive
  • Electromagnetic Compatibility (EMC) directive

The Medical Devices directive is administered by Medsafe, a division of the Ministry of Health.
The remaining three directives, Simple Pressure Vessels, Machinery, and Radio Equipment and Telecommunications Terminal Equipment, still await laboratories to have them included in their activities.

Conformity Assessment Bodies
It is necessary to satisfy CE Marking requirements before the products can be legally sold on the European market. An independent Conformity Assessment Body (CAB) may need to confirm that requirements are met. A CAB is designated as such by a Designated Authority (see section below) established by the New Zealand Government under an Agreement with the European Union. This Agreement enables the testing, inspection and certification for CE marking to be done in New Zealand and the results accepted in Europe.

NZ Designating Authorities
Under the Agreement with the European Union, the New Zealand Designating Authorities are:

International Accreditation New Zealand : Testing laboratories and inspection bodies
Ministry of Health : Medical devices and human pharmaceuticals
Joint Accreditation System for Australia and New Zealand : Systems and product certification management

Registration criteria
Testing laboratories and inspection bodies are registered by IANZ as a Conformity Assessment Body for CE Marking when they comply with Specific Criteria Designation of Assessment Bodies for European Regulatory Requirements.
A copy of this document is available on request from IANZ by phoning (09) 525 6655 or emailing us.

Links
Directives relating to the above products can be accessed from www.europa.eu.int

 

 

 

  
 
 
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