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.
- Identify the Applicable Legislation and Harmonised Standards
- Verify Product Requirements
- Identify if you can self-certify or need to use an Independent Conformity Assessment (by a Notified Body)
- Conduct the Conformity Assessment
- Create and keep the Required Technical File available
- Add the CE Marking and Draw up the EU Declaration of Conformity
Cost: 100 USD to 100'000 USD.
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