Compliance FAQs: CE Marking

This content last updated 08/29/2022. (Note: Content may not be the most current.)

• What is CE marking?
• Do all products sold in EU require CE marking?
• What are New Approach Directives?
• What are my responsibilities?
• What is Conformity Assessment?
• Do I need to have an Economic Operator in the EU?
• What are Harmonized Standards?
• Am I required to use Harmonized Standards?
• Once my product has the CE mark is it good for life?
• Where can I get additional information?

What is CE marking?

To strengthen the conditions for placing goods on the European market, the New Legislative Framework was adopted in 2008 with an aim to protect consumers and workers from unsafe products and boost the quality of conformity assessment. Part of this Framework included Decision 768/2008 – a common framework for the marketing of products, which lays down rules for CE marking.

CE Marking on a product is a manufacturer’s declaration that a product meets the applicable health, safety, and environmental requirements outlined in the appropriate European product legislation and has undergone the relevant conformity assessment procedure.

Do all products sold in EU require CE marking?

No. CE marking is compulsory for most products covered by the New Approach Directives. Products not covered under a New Approach Directive do not require CE marking. It is illegal to place a CE mark on a product that is not covered by a directive.

The following products require CE marking:

• Cableways
• Construction products
• Electronic equipment
• Equipment and protective systems for use in explosive atmospheres
• Explosives for civil use
• Gas appliances
• Hot water boilers
• Lifts
• Low-voltage electrical equipment
• Machinery
• Measuring instruments
• Medical devices, including active implantable medical devices and in vitro diagnostic medical devices
• Non-automatic weighing instruments
• Personal protective equipment
• Pressure equipment
• Radio and telecommunications terminal equipment
• Recreational craft
• Simple pressure vessels
• Toys

What are New Approach Directives?

The New Approach Directives define the essential requirements that products must meet when they are put on the market, but they do not give technical specifications to meet those requirements. Manufacturers may choose to use harmonized standards or another standard to comply with the essential requirements of the directive. Some products may require compliance to more than one directive.

The following is the current list of New Approach Directives:

• Cableway installations - Regulation (EU) 2016/424
• Construction products - Regulation (EU) No 305/2011
• Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU
• ATEX - Directive 2014/34/EU
• Pyrotechnic Articles - Directive 2013/29/EU
• Civil Explosives - Directive 2014/28/EU
• Gas appliances – Directive 2009/142/EC  Regulation (EU) 2016/426 (Effective April 21, 2018)
• Eco Design-Hot water Boilers - Directive 92/42/EEC
• Lifts - Directive 2014/33/EU
• Electromagnetic Compatibility - Directive 2014/30/EU
• Low Voltage - Directive 2014/35/EU
• Measuring Instruments - Directive 2014/32/EU
• Active Implantable Medical devices – Directive 90/385/EEC
• Non-automatic Weighing Instruments - Directive 2014/31/EU
• Personal protective equipment - Regulation (EU) 2016/425
• Simple Pressure Vessels - Directive 2014/29/EU
• Radio equipment - Directive 2014/53/EU
• Recreational craft and personal watercraft - Directive 2013/53/EU
• Transportable pressure equipment - Directive 2010/35/EU
• Pressure equipment - Directive 2014/68/EU
• Toy Safety - Directive 2009/48/EU
• Marine Equipment - Directive 2014/90/EU

What are my responsibilities?

Manufacturers, importers and distributors each have responsibilities.

For example, manufacturers must identify the applicable directive and verify the product meets the requirements, including having the product tested to check its conformity. The manufacturer must also determine if an independent conformity assessment is required. The manufacturer is responsible for affixing the CE marking, compiling a technical file (which includes all the documents that prove that the product conforms to the technical requirements), and drafting an EU Declaration of Conformity stating that the product meets all legal requirements.

A component or subassembly of machinery (per Machinery Directive only) that cannot be CE marked in its delivered state require a Declaration of Incorporation that states which aspects of the equipment the component/subassembly manufacturer is responsible for and which essential requirements have been fulfilled by them. Compliance with the other essential requirements is the responsibility of the manufacturer that assembles and CE marks the complete machine. A Declaration of Conformity is required from the final manufacturer/assembler for the completed product.

The EU Declaration of Conformity should contain key information including:

• Product Identification   
• Name and full address of the manufacturer or his representative
• A statement that the declaration is issued under sole responsibility of the manufacturer or authorized representative
• List of product safety directive it complies with
• List of harmonized standards or other applied technical standards and specifications
• Name and identification for the notified body, if applicable.
• Signature of representative of the organization placing it on the EU/EEA market.
• The date of declaration

The technical documentation and the EU Declaration of Conformity must be kept for 10 years after the product has been placed on the market or for the period specified in the directive.

Manufacturers are responsible for affixing the CE marking unless the importer or distributors market the product under its own name. In this case, the importer or distributor takes on the responsibilities of the manufacturer.

What is Conformity Assessment?

Conformity assessment is the process carried out by the manufacturer for demonstrating whether specified requirements relating to a product have been fulfilled. A product is subjected to conformity assessment both during the design and production phase and is the responsibility of the manufacturer, even if the manufacturer subcontracts the design or production.

Depending on the applicable legislation, there are many different conformity assessment options for manufacturers.  The 'Blue Guide' on the implementation of EU product rules 2022 contains some examples of conformity assessment options beginning on page 71.

Some of those options are:

• No requirement for third-party involvement in conformity assessment.  The manufacturer carries out all required controls and checks, establishing the technical documentation, and ensuring the conformity of the production process. The manufacturer then issues the Declaration of Conformity.
• An accredited in-house conformity assessment body that forms a part of the manufacturer's organization performs the conformity assessment. The in-house body must not have any activities other than conformity assessment and must be independent from any commercial, design, and production entities. It may have to demonstrate technical competence and impartiality through accreditation.
• A third-party, external conformity assessment body conducts the conformity assessment. They are referred to as Notified Bodies. Such a body must be impartial and fully independent from the organization or the product it assesses. For some products, such as those covered under the Gas Applicant Directive, this is mandatory. These bodies are authorized by national authorities and officially notified to the European Commission. They can be found on the NANDO (New Approach Notified and Designated Organisations) database.

Do I need to have an Economic Operator in the EU?

Yes, in accordance with the Market Surveillance Regulation (EU) 2019/1020, as of July 16, 2021, there must be an economic operator in the EU who can provide the market surveillance authorities with compliance information or takes certain action.  This economic operator must be identifiable on the product or its packaging or other documents before free circulation of the product be authorized.   

The EU has developed some detailed guidance on this topic. 

What are Harmonized Standards?

Harmonized standards are a special category of European standards that have been developed at the request of the European Commission to cover one or more essential requirements contained in EU legislation.  If reference to the harmonized standards has also been made in the Official Journal of the European Union (OJEU), compliance with the relevant section of the standard provides presumption of conformity with the essential requirements that the harmonized standard aims to cover. 

Below are links to regulations, directives, and other areas that have harmonized standards. The applicable harmonized standards are listed on these pages. It is not mandatory to use the special category of harmonized standards, but manufacturers must prove the product complies with essential requirements of the applicable Directive.
 

Topic	Regulation/Directives and Harmonized Standards
Chemicals	Chemical substances (REACH)
	Explosives for civil uses
	Pyrotechnic articles
Conformity assessment and management systems	New Legislative Framework (NLF) and Eco-Management and Audit Scheme (EMAS)
Construction	Construction products (CPD/CPR)
Consumers and workers protection	Cosmetics products
	General product safety
	Personal protective equipment (PPE)
	Toys safety
Energy efficiency	Ecodesign and energy labelling
Electric and electronic engineering	Electromagnetic compatibility (EMC)
	Equipment for explosive atmospheres (ATEX)
	Low Voltage (LVD)
	Radio Equipment (RED)
Healthcare engineering	Active implantable medical devices
	In vitro diagnostic medical devices
	Medical devices (MDD)
Measuring technology	Measuring instruments (MID)
	Non-automatic weighing instruments (NAWI)
Mechanical engineering and means of transport	Cableway installations designed to carry persons
	Equipment for explosive atmospheres (ATEX)
	Gas appliances (GAD)
	Inspection of pesticide application equipment
	Lifts
	Machinery (MD)
	Pressure equipment (PED)
	Rail system: interoperability
	Recreational craft and personal watercraft
	Simple Pressure Vessels (SPVD)
Services	Community postal services
Sustainability	Packaging and packaging waste

Am I required to use Harmonized Standards?

No.  You can choose whether or not to apply harmonized standards referenced in the OJEU. However, if you choose se not to apply the harmonized standards referenced in the OJEU, you must demonstrate that your product is in conformity with essential requirements by other means that provide the level of safety or protection required by the applicable legislation. You can use other standards such as national standards, international standards, European standards that are not referenced in the OJEU, or other technical specifications such as European standardization deliverables, or the manufacturer’s own specifications. In these cases, the manufacturer does not benefit from the presumption of conformity, and has to demonstrate the conformity.  This should be documented in the technical file of the relevant product, with details about how the standards or technical specifications used provide conformity with the essential requirements, for instance by carrying out a more in-depth risk assessment on the product, a gap analysis.  [reference:  Blue Guide, 4.1.3]

Once my product has the CE mark is it good for life?

The EC Declaration of Conformity and CE mark are valid as long as your product meets the applicable health, safety, and environmental requirements of the directive(s) at the time the products are placed/put into service on the market in the EU. If you have changes in product design or characteristics, you may have to undergo additional conformity assessment activities (including, for example, re-testing or use of a Notified Body) to ensure it is still in compliance with the appropriate directive. In addition, changes to the applicable legislation and/or to the harmonized standards may also result in the product needing additional conformity assessment activities to demonstrate compliance.  Upon entry into force of any new legislation applicable to your products, your EC Declaration of Conformity must be updated for additional products being placed/put into service on the market.

Where can I get additional information?

The EU has published a detailed guide explaining EU’s product rules and CE Marking.  See the EU’s Blue Guide (2022).

U.S. exporters needing more information on the CE mark and how it might apply to their product can also contact Bob Straetz at the Commerce Department in Washington at 202-482-4496 (Robert.Straetz [at] trade.gov ()).

 

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