CE, FCC, and EG product certification

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What product needs what certification?

  • Directive 2006/42/EC on Machinery
  • Directive 2000/14/EC on Noise Equipment for use outdoors
  • Directive 2000/9/EC on Cableway Installations
  • Directive 2009/125/EC on Energy-Related Products
  • Directive 2009/142/EC on Gas Appliances
  • Directive 2009/48/EC on Toy Safety
  • Directive 2011/65/EU on the restrictions of the use of certain hazardous substances in electrical equipment
  • Directive 2013/29/EU on Pyrotechnic Articles
  • Directive 92/42/EEC on Hot Water Boilers
  • Directive 2014/28/EU on Explosives for civil uses
  • Directive 2014/29/EU on Pressure Vessels
  • Directive 2014/30/EU relating to Electromagnetic Compatibility
  • Directive 2014/31/EU on Weighing Instruments
  • Directive 2014/32/EU on Measuring Instruments
  • Directive 2014/33/EU on Lifts
  • Directive 2014/34/EU relating to equipment and protective systems for use in potentially explosive atmospheres.
  • Directive 2014/35/EU relating to the making available on the market of electrical equipment designed for use within certain voltage limits
  • Directive 2014/53/EU relating to Radio Equipment
  • Directive 90/385/EEC on Active Implantable Medical Devices
  • Directive 2013/53/EU on Recreational Craft
  • Directive 2014/68/EU on Pressure Equipment
  • Directive 98/79/EC on in vitro diagnostic medical devices
  • Regulation (EU) No 305/2011 on Construction Products
  • Regulation (EU) 2017/745 on Medical Devices
  • Regulation (EU) 2016/425 on Personal Protective Equipment

How do you certify your products?

For low-risk products self-certification is enough. It is also possible to simplify the certification process if the underlying components are in turn certified themselves.

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Certification process

  1. Identify the Applicable Legislation and Harmonised Standards
  2. Verify Product Requirements
  3. Identify if you can self-certify or need to use an Independent Conformity Assessment (by a Notified Body)
  4. Conduct the Conformity Assessment
  5. Create and keep the Required Technical File available
  6. Add the CE Marking and Draw up the EU Declaration of Conformity

Cost: 100 USD to 100'000 USD.

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