CE marking

With the CE marking, the manufacturer or EU representative in accordance with EU Regulation 765/2008, " that the product meets the applicable requirements set out in Community harmonization legislation providing for its affixing. "

The letters " CE " were initially (1985 ) in four of the nine EC official languages ​​for " Communauté Européenne ", " Comunidad Europea ", " Comunidade Europeia " and " Comunità; Europea "on German European Community ( EC). For this reason, "CE" in the 1980s was in Germany equated quite literally with "CE" and the original " CE mark " was in Germany in accordance in all the then European harmonization directives approximation of national legal regulations ' EC mark'.

The CE marking is not a (test ) "seal", but an administrative character that expresses the free marketability of their marked industrial products in the European single market.

The marking shall consist of the CE logo (if any) in connection with the four-digit identification number of the Notified Body involved, if this was concerned with the conformity check.

History

By 1993, the CE marking was still called " CE mark "; the official name has since read " CE marking ". This designation was for all harmonization directives already adopted introduced by Council Directive 93/68/EEC of 22 July 1993 amending Directives

  • 87/404/EEC ( simple pressure vessels ),
  • 88/378/EEC (safety of toys),
  • 89/106/EEC ( construction products ),
  • 89/336/EEC (electromagnetic compatibility),
  • 2006/42/EC (machinery),
  • 89/686/EEC (personal protective equipment ),
  • 90/384/EEC (non -automatic weighing instruments ),
  • 90/385/EEC (active implantable medicinal devices),
  • 90/396/EEC ( appliances burning gaseous fuels ),
  • 91/263/EEC ( telecommunications terminal equipment ),
  • 92/42/EEC ( with liquid or gaseous fuels, new hot water boiler) and
  • 73/23/EEC ( electrical equipment designed for use within certain voltage limits ) (published in the OJ. EC No. L 220/1 of 30 August 1993 ).

In the field of medical devices was the correct term from the beginning " CE marking " (see Article 17 and Annex XII of Directive 93/42/EEC).

Due to the official stance of the European Commission, Directorate-General for Enterprise and Industry ( Regulatory Policy ), the stylized letter combination is a graphic symbol since 1994.

Initially, the letters "CE" in four out of nine EU languages ​​still with " EC " for "European Community" equated ( " Communauté Européenne ", " Comunidad Europea ", " Comunidade Europeia " and " Comunità Europea " ), as well as in the former German legislation ' EC mark' is called. According to information from the European Commission, the graphic symbol "CE" has no literal meaning more today, but is a symbol of free trade capacity in the EU.

By affixing the CE marking, the manufacturer confirms that the product is the product-specific applicable European Directives (since 1 December 2009 with the enactment of the " Lisbon Treaty ": EU - Directions). The CE logo alone does not allow any conclusions as to whether the product was checked by independent bodies for compliance with the guidelines. However, if under the logo of a four-digit identification number (identification number) attached, this points to the involvement of a Notified Body in the conformity assessment procedure. The CE marking is legally not a seal of quality (quality mark ), but documented on the contrary, only the adherence to the legally permissible minimum requirements.

Depending on the CE marking underlying sectoral harmonization Directive, it can still be effectively viewed as a quality mark.

Legal specialties for medical devices

Unlike other industrial products need medical devices according to the "basic requirements " of Directive 93/42/EEC ( Annex I) and Directive 90/385/EEC (Annex 1) is not only safe, but also within the parameters set by the manufacturer to be medical- technical be efficient, which today in industrial practice under a certified quality management system according to EN ISO 13485, Title: " Medical devices - Quality management systems - requirements for regulatory purposes " (ISO 13485:2003 Corr 1:2009. ), German version: EN ISO 13485 2012, can be demonstrated. The EN ISO 3485 is the sectoral harmonized successor standard to ISO 9001, identical to EN 29001 ( the " Modules Decision " 1993 referenced) and the old EN 46,001th your attention in addition to fulfilling the statutory essential requirements leads to the presumption of conformity.

As far as external Notified Bodies involved in the conformity assessment of medical devices, which of these certificates of conformity issued (certificates) exceeding five years thereafter, a new certification audit, which sets the current level of technology to scale. Be additional six - monthly to yearly re-certification audit of quality management system by the Notified Body. The situation is different, for example, in the U.S., where a once- approved medical device by the Food and Drug Administration ( FDA) is a second time viewed and examined.

The in the EU directives legally certain " essential requirements ", eg for sterility and biological safety of medical devices, which are given the EU Commission in order to harmonized European standards ( mandated ), and checks described in detail. All harmonized standards will be made ​​in the EU Official Gazette and revised at least every five years and adapted to each new state of the art.

For this reason it is inappropriate to equate the meaning of the CE marking on medical products with the toy on or iron. The creation of a sectoral CE marking of its own kind appears to better outward visibility for medical products appropriately, eg " CE med".

Development and function

The CE marking was primarily created to the final consumer safe products within the overall 30 States Parties European Economic Area, including the European Community ( EC), today: to ensure European Union (EU ). The CE marking is often called a " passport" for the single European market called.

EU directives under Article 288, paragraph 3 TFEU (so-called internal market and harmonization guidelines ) define for numerous products safety and health requirements as minimum requirements that must not be exceeded. A product may only be first placed on the market and first put into operation if it meets the essential requirements of all applicable EU directives, and if to prove the legal conformity of a conformity assessment procedure according to the method described in Annex II of Decision No 768 / 2008/EC of the European Parliament and of the Council of 9 July 2008 on a common regulatory framework for the marketing of products and repealing Decision 93/465/EEC (OJ L 218 /82) has been performed.

As part of the new approach to product regulation and global approach to conformity assessment Regulatory were created that are intended for technical harmonization within the EU internal market.

All legislation affecting the CE marking are part of the " New Approach Review" ( revision of the ' New Approach ' ) in Regulation ( EC) No 765/2008 and Decision No 768/2008/EC, both been revised July 9, 2008:

  • Recitals 37 and 38 ( CE marking as ' only ' conformity marking )
  • Chapter IV ( = Article 30: " General principles - Rules and conditions for affixing the CE marking " ),
  • Annex II ( " CE marking " - typeface )

And

  • Article R 11: " General principles of the CE marking ", referring to Article 30 of the EC Regulation No 765 /2008 and
  • Article R 12: " Rules governing the affixing of the CE marking ".

Article R 12, paragraph 4 is (identical with Article 30, paragraph 6 of EC Regulation 765/2008 ): "The EU Member States shall build upon existing mechanisms to ensure proper implementation of the regime governing the CE marking and take in the case of abusive Use appropriate action. The Member States shall also provide penalties for infringements, which may be at serious infringements ".

This is the first time since the introduction of CE marking her abuse sanctioned by graphically or content confusingly similar mark or criminalized (see § 9, paragraph 1, sentence 2 German Medical Devices Act - MPG: " Any other mark may on the medical device, packaging, or instructions for use of the medical device to be mounted, if they affect " not the visibility, legibility and meaning of the CE marking. ).

With the CE marking, the manufacturer indicates that the product complies with the according to the appropriate harmonization Directive to be met "basic requirements " on. Responsible for this marking usually the manufacturer of the product ( for manufacturers outside the EU is a representative established in the EU authorized representative is required). If the manufacturer outside the EU has failed to fulfill its obligation, the obligation goes to his representative in the EU, ultimately to the distributors about.

Important features of the CE marking

  • Products that due to their nature or type one or more of the EU directives applies, must be provided with the CE mark, before they are first placed on the market or put into service. There are to consider all applicable directives.
  • Manufacturer of a technical product test in its own responsibility which EU directives they have to apply in production.
  • The product should not be placed on the market and put into service only if it complies with all applicable guidelines at the current time and if the conformity assessment for all applicable directives has been made.
  • The manufacturer must draw up the EC declaration of conformity and affix the CE marking to the product.
  • If required, is to turn a Notified Body for conformity assessment.
  • In addition to the CE marking no other signs or labels are permitted, which can make the statement of the "CE" in question. ( There are always discussions about the German GS mark, that content is not the scope of CE marking covers ).
  • The CE marking certifies full compliance with the "essential ( safety) requirements " that are specifically defined in EU directives.
  • Exceptions to this rule are made only if specific guidelines provide otherwise, provisions.
  • An important part within the conformity assessment procedure, the risk assessment dar. This is performed currently by the harmonized European standard EN ISO 12100:2010. This is a basic safety standard (A standard). As an alternative to this general method, in the case of the presence of a specific product standard ( C standard ) for specific types of machines (eg presses, ...) the possibility to carry out a risk assessment according to the C standard.

Affixing of the CE marking

  • The CE marking is only valid for products that. After May 7, 1985, the date of the Council Resolution on a new approach in the field of technical harmonization and standards, OJ No C 136 /1, were placed on the market.
  • The CE marking must be affixed visibly, legibly, be distinctively and permanently marked on the product or on the label attached to it by the manufacturer or his authorized representative within the Community. The size must be at least 5 mm; at reduced or enlarged the proportions of the CE marking must be followed. If the nature of the product is not possible or this is no reason, it is on the packaging (if any) and to the accompanying documents, where the directive concerned provides for such documents.
  • If a Notified Body in accordance with the applicable policies in the production control is switched on, the identification number of the notified body adjacent to the CE marking must stand. When affixing the identification number of the manufacturer or his agent established in the Union representative the Notified Body is responsible.
  • The CE marking may only be made if all EU directives are met, which are applicable for the respective product.

Territory to

The CE marking is a prerequisite for the entry (or commissioning ) of products for which a CE marking in accordance with the following EU directives is required, namely in all member states of the European Economic Area ( EEA). The EEA comprises the EU Member States and the EFTA states except Switzerland. Thus, when marketed in Switzerland, the CE marking is not required. There are many special mark of conformity, CE marking according to EU directives is acknowledged.

The situation is different for the sector " medical devices":

Switzerland has with the EU ( then called " EC " ) on 21 June 1999 to an international " agreements on mutual recognition of conformity assessment ", in Annex 1, the Sectoral Chapter 4 ( " Medical " ) provides that Swiss manufacturer CE marking under EU law even attach to medical devices. Conversely Switzerland accepts the importation of medical devices bearing the CE marking in their own country ( reference: . OJ No L 114/369 of 30 April 2002 ). Comparable third country agreements exist between the EU and Australia, New Zealand, Canada and the USA.

Decision No 1/95 of the EC- Turkey Association Council of 22 December 1995 on implementing the final phase of the Customs Union (OJ No L 35/1 of 13 February 1996 ) provides for the quasi- inclusion of Turkey in the EU internal market for medical products before.

Affected product groups or technical fields

For the following product groups there are European directives or EU regulations according to the principles of the " New Approach " as a basis for CE marking:

  • Household refrigerators and freezers ( 96/57/EC ),
  • Electrical equipment ( 2006/95/EC),
  • Simple pressure vessels ( 2009/105/EC )
  • Toys (2009/48/EC ),
  • (89/106/EEC, the EU Construction Products Regulation 305/2011 replaced from 1 July 2013)
  • Electromagnetic Compatibility ( Electrical and electronic products, 89/336/EEC, 2004/108/EC since July 19, 2009 )
  • Personal protective equipment (89/686/EEC ),
  • Non-automatic weighing instruments ( 90/384/EEC, amended by 2009/23/EC as of 5 June 2009),
  • Active implantable medical devices ( 90/385/EEC, amended by 2007/47/EC as of 21 March 2010),
  • Gaseous fuels ( 90/396/EEC),
  • Hot water boilers ( 92/42/EEC ),
  • Explosives for civil uses ( 93/15/EEC ),
  • Pyrotechnic articles ( 2007/23/EC ),
  • Medical devices ( 93/42/EEC, amended by 2007/47/EC as of 21 March 2010),
  • Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres ( 94/9/EC )
  • Sports Boats ( 2003/44/EC ( changed the 94/25/EC ) - see also: CE Seetauglichkeitseinstufung )
  • Lifts ( 95/16/EC ),
  • Pressure Equipment Directive ( 97/23/EC),
  • Machinery (Machinery Directive 98/37/EC, since December 29, 2009 2006/42/EC),
  • In vitro diagnostic medical devices (Directive 98/79/EC ),
  • Radio equipment and telecommunications terminal equipment and ( 99/5/EC )
  • Cableway installations designed to carry persons ( 2000/9/EC )
  • Measuring instruments ( 2004/22/EC )
  • Ecodesign Directive ( 2009/125/EC )

Regulated product areas without CE marking

For the following product groups there are regular guidelines according to which, however, no CE marking is provided, or are provided for the other mark of conformity:

  • Packaging and Packaging Waste ( 94/62/EC ),
  • Interoperability of the rail system within the Community ( 2008/57/EC ) as a replacement for the directives 96/48/EC ( interoperability of the trans-European high -speed rail system ) and 2001/16/EC ( Interoperability of the trans-European conventional rail system )
  • Marine Equipment Directive (96/98/EC ); Conformity mark: control wheel
  • Technical Work Equipment and Consumer Products ( 2001/95/EC ) applies if no additional policy with mandatory labeling of these products

Legal implications

Again and again get products to the European market, the construction of which is not an EU declaration of conformity to reason. They carry the CE marking therefore wrong. The CE marking of a product or the issuance of declarations of conformity without an operation carried out conformity assessment violates the law and, as necessary, criminal proceedings by themselves.

The 6th Civil Division of the Frankfurt Higher Regional Court ruled in June 2012: " The term" CE approved " for a product is misleading, if the user only confirmed with the CE mark even the conformity of the product with the relevant regulations. "

The OLG Zweibrücken defined with appeal judgment of 30 January 2014 ( ref. 4 U 66/13 ) the legal liability meaning of the CE marking, as follows:

"Liability Legally not even contain such marks a guarantee commitment from which the product purchaser may make contractual claims against the manufacturer for defects in quality claims ( see BGH NJW 1974, 1503). If such signs already against the manufacturer have no legal liability Relevance, which applies a fortiori from the certifying "Notified Body " which has only to check the manufacturer's quality management system. "

Rumors about the improper use of a similar mark (China export)

In the course of heaping reports of non- compliant "Made in China" toys, but also in the fight against piracy, unfair uses of the CE marking have been found. In this context, often rumors of a supposedly almost indistinguishable from the original CE marking. Here are the attached at a shorter distance letters "CE", the abbreviation "China Export" symbolize. To this topic has filed in November 2007, the EU Commission a parliamentary question ( P-5938/07 ) Zuzana Roithová ( on International Trade Deputy of the EU Committee ).

In its reply of 9 January 2008 said Industry Commissioner Günter Verheugen, that he is no evidence for a selective use of the CE marking in connection with the abbreviation " China Export " were available. As with any brand was an abuse can not be prevented, regardless of whether products with an abusive labeling in China or have been obtained elsewhere. The monitoring of the market and the removal of products that do not meet the requirements, is for the Member States. The Commission 'm in constant talks with the Chinese authorities to ensure that exports from there comply with the relevant Community legislation in the EU.

The misuse of the CE marking was previously heavily discussed especially in Italy, as the port of Naples is considered the actual gateway for counterfeit goods from China.

Water heating ATEX directive Oberlandesgericht
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