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CE MARKING



CE标识.jpg

The letters "CE"appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.


By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.


There are two main benefits CE marking brings to businesses and consumers within the EEA:

  • Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.

  • Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.

    WHO IS RESPONSIBLE FOR CE MARKING?

    The CE marking requirements covers different aspects of a product’s design, production and distribution. Typically, various companies are involved in the design, manufacturing, distribution and placing on the market of products. The contributions of each single of these links in the production chain and distribution chain may affect the CE compliance of a product. For example, a product may be designed in accordance with the requirements, but may in the end not comply because during the production stage there was a deviation from the design. Or an electronic component may have been tested and approved for the requirements for electromagnetic interference, but can start to emit illegitimate disturbance when installed incorrectly. This raises the question of who is responsible for the CE marking.

    The European CE marking directives, intend to make one person the main responsible and accountable for CE compliance. The way to identify that responsible person is rather unique for these directives. One would expect that the directives state that the ’manufacturer’ is responsible for CE marking. But instead they define two moments in time when the responsibility for CE starts:

    According to the text of the CE directives, a product must comply with the CE requirements and have a CE marking from the moment it is:

    – placed on the Community market for the first time;

    – put into service in the Community market for the first time.


THE REGULATORY REQUUIREMENTS FOR EUROPEAN MARKET ACCESS


SCOPE

                            LEGISLATIONS

Medical Devices

2006/42/EC

Construction Products

Regulation (EU) No 305/2011

Pressure Equipment

2014/68/EU

Low Voltage Directive

2014/35/EU

Electromagnetic Compatibility

2014/30/EU

Energy-Related Products(Erp)

2009/125/EC

Medical Devices

MDD 93/42/EEC

MDR Regulation (EU) 2017/745

In Vitro Diagnostic Medical Devices

IVDD 98/79/EC

IVDR Regulation (EU) 2017/746

Toys

2009/48/EC

Radio Equipment

R&TTE 1999/5/EC

RED 2014/53/EU

Personal Protective Equipment

89/686/EEC

Regulation (EU)2016/425

General Product Safety Directive

2001/95/EC

Environmental Protection Certification

ROHS 2011/65/EU

Waste Electrical And

Electronic Equipment

WEEE 2002/96/EC