Product 1

QQQQ copy.gif

Introduction to CE Marking

CE mark.jpg

CE Marking (CE-Marking), also called "CE Mark", is a mandatory mark for many (around 70%) of the products sold on the EFTA plus European Union (EU) market (total 28 countries) and it is often referred as the "Trade Passport to Europe" for non-EU products.

EU legislation makes EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them. The liability claims in a law suit can be as high as 70 millions EUROs.

CE Marking may be achieved through several modules. One of the most practical ways, which is preferred by many EU importers, is that the manufacturer designates an Authorized Representative in the EU member states who will take care of the CE Marking issue therefore the importers and/or distributors can focus on the marketing and sales of the products. The manufacturer may need only ONE Authorized Representative in EU whereas may have many importers and/or distributors.

The Authorized Representative may in some cases register the product(s) in the EU member states and thus obtain a Certificate of Registration. The Product Certificate of Registration for CE Marking obtained from one EU member state is valid for the entire EFTA plus EU market, i.e. 28 countries.

In general, CE Marking is most probably required if you want to sell, to the 25 European Union (EU) and 3 European Free Trade Association (EFTA) member states, the following 22 groups of products -

Toys, appliances burning gaseous fuels, cableway installations to carry persons, construction products, electrical equipment, equipment and protective systems for explosive atmospheres, explosives for civil uses, hot water boilers, household refrigerators & freezers, lift, machinery, marine equipment, measuring instruments, medical devices, active implantable medical devices, in vitro diagnostic medical devices, non-automatic weighing equipment, personal protective equipment, pressure equipment, simple pressure vessels, recreational craft, radio equipment & telecommunications terminal equipment, and trans-European conventional rail system.

Directives based on the principles of the New Approach which provide for CE marking

	Directives based on the principles of the New Approach which provide for CE marking	Number of directive amendment	Reference in OJEC (corrigendum) amendment
1	Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits	73/23/EEC 93/68/EEC	OJ L 77 of 26/03/73 (OJ L 181 of 04/07/73) OJ L 220 of 30/08/93
2	Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels	87/404/EEC 90/488/EEC 93/68/EEC	OJ L 220 of 08/08/87 (OJ L 31 of 02/02/90) OJ L 270 of 02/10/90 OJ L 220 of 30/08/93
3	Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys	88/378/EEC 93/68/EEC	OJ L 187 of 16/07/88 (OJ L 281 of 14/10/88) (OJ L 347 of 16/12/88) OJ L 37 of 09/02/91) OJ L 220 of 30/08/93
4	Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products	89/106/EEC 93/68/EEC	OJ L 40 of 11/02/89 OJ L 220 of 30/08/93
5	Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility	89/336/EEC 92/31/EEC 93/68/EEC	OJ L 139 of 23/05/89 (OJ L 144 of 27/05/89) OJ L 126 of 12/05/92 OJ L 220 of 30/08/93
6	Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment	89/686/EEC 93/68/EEC 93/95/EEC 96/58EC	OJ L 399 of 30/12/89 OJ L 220 of 30/08/93 OJ L 276 of 09/11/93 OJ L 236 of 18/09/96
7	Council Directive 90/384/EEC of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments	90/384/EEC 93/68/EEC	OJ L 189 of 20/07/90 ( OJ L 258 of 22/09/90) OJ L 220 of 30/08/93
8	Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices	90/385/EEC 93/42/EEC 93/68/EEC	OJ L 189 of 20/07/90 (OJ L 7 of 11/01/94) (OJ L 323 of 26/11/97) OJ L 169 of 12/07/93 OJ L 220 of 30/08/93
9	Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels	90/396/EEC 93/68/EEC	OJ L 196 of 26/07/90 OJ L 220 of 30/08/93
10	Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels	92/42/EC 93/68/EEC	OJ L 167 of 22/06/92 (OJ L 195 of 14/07/92) (OJ L 268 of 29/10/93) OJ L 220 of 30/08/93
11	Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses	93/15/EEC	OJ L 121 of 15/05/93 (OJ L 79 of 07/04/95)
12	Council Directive 93/42/EEC of 14 June 1993 concerning medical devices	93/42/EEC 98/79/EC 2000/70/EC	OJ L 169 of 12/07/93 (OJ L 323 of 26/11/97) (OJ L 61 of 10/03/99) (OJ L 125 of 19/05/99) (OJ L 72 of 14/03/01) OJ L 331 of 07/12/98 (OJ L 313 of 13/12/00)
13	Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres	94/9/EC	OJ L 100 of 19/04/94 (OJ L 257 of 10/10/96) (OJ L 21 of 26/01/00) (OJ L 304 of 05/12/00)
14	Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft	94/25/EC 2003/44/EC	OJ L 164 of 30/06/94 (OJ L 127 of 10/06/95) (OJ L 17 of 21/01/97) (OJ L 41 of 15/02/00) (OJ L 214 of 26/08/03)
15	European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts	95/16/EC	OJ L 213 of 07/09/95
16	Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment	97/23/EC	OJ L 181 of 09/07/97 (OJ L 265 of 27/09/97) (OJ L 250 of 23/09/99
17	Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery	98/37/EC 98/79/EC	OJ L 207 of 23/07/98 (OJ L 16 of 21/01/99) (OJ L 80 of 25/03/99) OJ L 331 of 07/12/98
18	Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices	98/79/EC	OJ L 331 of 07/12/98 (OJ L 22 of 29/01/99) (OJ L 74 of 19/03/99) (OJ L 124 of 25/05/00) (OJ L 6 of 10/01/02)
19	Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity	1999/5/EC	OJ L 91 of 07/04/99
20	Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons	2000/9/EC	OJ L 106 of 03/05/00
21	Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments	2004/22/EC	OJ L 135 of 30/04/2004