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CE

Overview

CE logo

European Economic Community(EEC) established in 1958 → Single European Act signed in Dec. 1985 (Removal of technical and physical barriers in European markets by Dec 31st 1992) → CE mark established by the EC council directives 93/68/EEC in Jul. 1993

Conformite Europeenne mark (CE mark) is created to ensure safety of products manufactured and distributed in the European markets.
This designates that the manufacturer, importer or third party (notified body) has conducted the related conformance assessment so that the products may be distributed in the market without any restrictions.
The CE mark doesn’t guarantee the reliability or quality of products, but it means that the products abide by the necessary requirements of the EC Regulations or Directives and European Standards related to health, safety and consumer protection.

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Procedure

Procedure

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References of harmonised standards and of other European standards published in the OJEU

Directive Shot Title Object items EC directives no.
MD Machinery Directive Industrial machinery 2006/42/EC
LVD Low Voltage Directive AC 50V-1000V, DC75V-1500V electric devices 2014/35/EU
EMCD Electro-magnetic Compatibility Directive Most electric and electronic devices 2014/30/EU
MDR Medical Device Directive Medical devices EU 2017/745
IVDR In Vitro Diagnostic Device Blood test, etc. EU 2017/746
LIFT Lifts Directive Lifts 2014/33/EU
ATEX Equipment for potentially explosive atmospheres Explosion proof 2014/34/EU
TOY Toy Safety Directive Toys (for children ages 14 or less) 2009/48/EC
SPVD Simple Pressure Vessels Directive 0.5bar or higher pressure vessels and accessories 2014/29/EU​
GAS Gas Appliances Gas appliances EU 2016/426
RED Radio Equipment Directive Wire, radio communication terminals 2014/53/EU
NAWI Non-automatic weighing instruments Industrial medical weighing instruments 2014/31/EU
PPE Personal Protective Equipment Personal Protective Equipment EU 2016/425
CPR Construction Products Regulation Cement, tile, sanitary ware, wood door, revolving door, etc. 89/106/EEC
EU 305/2011
Cableway
installations		 Cableway installations designed to carry persons Cableway for transporting persons (cable car, etc.) EU 2016/424
PED Pressure Equipment Directive Pressure equipment, vessels 2014/68/EU
Civil Uses Explosives For Civil Uses Explosives For Civil Uses except for military or police uses 2014/28/EU
RCD Recreational Craft Directive Small ships 2013/53/EU
MID Measuring instruments Instruments for measuring 2014/32/EU
Packaging
Waste		 packaging and packaging waste Packaging vessels 94/62/EC
Pyrotechnics Pyrotechnic articles Car airbag, etc. 2013/29/EU
ROHS Restriction of the use of certain hazardous substances Electronics 2011/65/EU

Conformity assessment procedure

Module A
(Internal production control)		 Internal production control for design and production
No legal intervention from the Europe Notified Body		 Declaration of Conformity (DoC)
Module B
(EC-type examination)		 The design and sample are submitted for inspection to the Notified Body Certificate of Conformity (CoC)
Module C
(Conformity to type)		 The manufacturer ensures continuous production of the products inspected according to the Module B.
(No intervention from the Notified Body) 		B+C (Manufacturer’s guarantee of safety after CoC)
Module D
(Production quality assurance)		 The Notified Body approves final inspection and test quality procedures for the production process of the products inspected according to the Module B. B+D (Notified Body’s guarantee of safety after CoC)
Module E
(Product quality assurance)		 The Notified Body approves final inspection and test quality procedures for the products inspected according to the Module B. Verification with products only
Module F
(Product verification)		 The Notified Body type-examines and approves whether the safety design and data for the products, inspected and certified according to the Module B, are applied to the same type of production process. Factory inspection
Module G
(Unit verification)		 Notified Body totally inspects and approves all the corresponding unit products.
Module H
(Full quality assurance)		 Notified Body approves whether the design, manufacturing, production, final inspection and test are maintained according to the essential requirements and ISO 9001.