CE Certification Requirements

CE marking on a product is confirmation that the product meets all regulations required in European Union law and passed the relevant inspection.

All equipment is to comply with the requirements of EN 62471 and CE certification thereof. Equipment shall be certified by a national or third-party certification body accredited according to ISO/IEC 17065:2006, or alternative schemes pursuant to Article 4.1 of the R&TTE Directive 1999/5/EC.

CE certification includes “harmonized standard” equipment as follows:

EN 62471, Radio Equipment and Systems (RES) for Land Mobile Services

Note 1: Further details regarding “harmonized standards”, including applicable standards, can be found in EN0009-1 – Harmonized Standards.

Note 2: For the purposes of this document, the term “harmonized standards” means harmonized standards as defined in Article 2(d) of Directive 97/23/EC and for which the CE marking is mandatory.

Consultation with radio spectrum authorities is required to ensure that the use of equipment causes no harmful interference, either intentional or unintentional, to other radio communications systems, and that it complies with any applicable national rules.

The applicant must identify and conduct frequency coordination for each radio frequency band in which their equipment is intended to operate. Such coordination should be conducted according to the relevant requirements of your local regulatory authority. Alternative schemes may be used under Article 4.1 of the R&TTE Directive 1999/5/EC.

The applicant must submit the following to a national or third-party certification body accredited according to ISO/IEC 17065:2006, or alternative schemes pursuant to Article 4.1 of the R&TTE Directive 1999/5/EC for CE marking:

  • A Type Exam Report (TER), unless the equipment is for use onboard vessels or aircraft registered in a country outside the European Economic Area, and is already CE marked.
  • A technical construction file
  • Declaration of Conformity

The applicant must ensure that their product has undergone sufficient electromagnetic compatibility testing prior to an application for certification. Such testing is to be carried out in accordance with the applicable requirements of EN 301 489, Compliance and Emission Testing for Radio Equipment (RES).

The applicant must ensure that their product has been assessed for the relevant environmental conditions prior to an application for certification. The applicant must demonstrate that the equipment can operate successfully over its specified temperature range without degrading.

An EU Declaration of Conformity is a document issued by the manufacturer or authorized representative to confirm that the equipment meets specific harmonized standards and essential requirements of Directive 2014/53/EU, (the “Radio Equipment Directive”) and that it has been subject to compliance testing. It certifies that from a technical viewpoint all conditions necessary for compliance with the essential requirements of the Directive have been fulfilled.

The EU Declaration of Conformity shall contain: A description and technical specifications of the radio equipment A statement that all necessary steps to comply with applicable standards and other legal provisions (e.g., relating to electromagnetic compatibility, environmental protection) have been taken Name(s) and address(es) of the manufacturer(s), authorized representative(s), importer(s) or any other entity responsible for placing the equipment on the market A statement that all necessary steps to ensure continued compliance have been taken The EU Declaration of Conformity shall be issued in one of the following languages: English, French, German or Italian.

A Declaration of Conformity issued in accordance with the R&TTE EEA Annex is valid throughout all states of the European Union and EEA.

The EU Declaration of Conformity should be submitted together with any other relevant application, e.g., for type approval or market surveillance purposes. For equipment not requiring a declaration of conformity (see Article 4 of the R&TTE Directive) or for equipment for which you have previously been issued with an EU Declaration of Conformity, this declaration is not required by the notified body.

If you are placing radio equipment on the market and it requires a Declaration of Conformity or a Type Exam Report, please note that these procedures may take 2 to 3 months to complete and you should plan accordingly.

For more information go here: Overview of the Declaration of Conformity procedure and Type Examination (TE) procedure.

Requirements for Machinery Directive 2014/30/EU

Machinery Directive 2014/30/EU on the harmonization of the laws of Member States relating to machinery, is a piece of European legislation aiming to ensure that all machines which are subject to certain essential health and safety requirements can circulate freely in the internal market.

The Machinery Directive applies to machinery placed on the market in the European Economic Area (EEA), which is a territory comprising of all EU Member States, along with Norway, Iceland and Liechtenstein.

As such, the requirements for CE marking applicable to products falling within the scope of the Machinery Directive 2014/30/EU are those laid out in Article 14 of this Directive and harmonized by European standards EN 60745-1:2009 and -2:2011.

The Machinery Directive requires that all machinery placed on the market within the EEA must be CE marked, accompanied by a Declaration of Performance (DoP) and have been assessed by a Certification body to meet defined essential health and safety requirements outlined in harmonized European standards.

There are basically two CE marking options for machinery: Declaration of Performance (DoP) or conformity to harmonized European standard EN 60745-1:2009.

A Declaration of Performance is a statement issued by the manufacturer that their machinery complies with all essential health and safety requirements as defined in harmonized standard EN 60745-1:2009.

It is not deemed necessary to carry out a full, potentially costly, type-examination as required under the conformity to harmonized European standard option.

The DoP is therefore a quick and cost-effective method for machinery manufacturers to place their products on the market.

Requirements for In-Situ Equipment Directives 2014/53/EU and 2014/54/EU

The In-Situ Equipment Directives 2014/53/EU and 2014/54/EU are designed to ensure that in-situ equipment does not cause damage to an installation when it is used.

In-situ equipment is any machine or physical system (e.g., a chemical treatment system) permanently installed in an industrial plant, building, structure or facility to perform a specific function.

The two directives address the issue of in-situ equipment posing a risk to plants and installations and require that manufacturers demonstrate their products conform with European standards EN 61800-5-1:2007 and EN ISO 13849-2:2006 respectively.

Requirements for Low Voltage Directive 2014/35/EU

The Low Voltage Directive 2014/35/EU harmonizes the laws of all EU Member States relating to electrical equipment designed for use within certain voltage limits (i.e., low voltage). It is a piece of European Legislation aimed at ensuring that consumer and industrial electrical equipment placed on the market comply with specific essential health and safety requirements.

The Low Voltage Directive applies to the following low voltage electrical equipment:

  • Electrical lighting;
  • Domestic heating appliances;
  • Wiring devices for use within certain voltage limits (i.e., low voltage); and,
  • Distribution transformers of a power not exceeding 50 kV.

Requirements for medical devices Directive 93/42/EEC

The Directive defines medical devices as any object or system designed, manufactured, and used for the same purpose namely to protect against potential diseases, to aid diagnosis, cure or treat human beings.

It requires that all medical devices placing on the market in the European Economic Area (EEA), which is a territory comprising of all EU Member States, plus Norway, Iceland, and Liechtenstein, be CE marked.

The Medical Device Directive [93/42/EEC] requires the manufacturer to ensure that products meet specified essential requirements outlined in harmonized European standards EN 60601-1:1994 + A11:2010/A2:2015 – Medical Electrical Equipment – Part 1: General Requirements for Safety and EN 60825-1:2012 – Medical electrical equipment – Electromagnetic compatibility.

Requirements for Personal Protective Equipment (PPE) for Construction Directive 89/686/EEC

The PPE Directive 89/686/EEC aims to ensure that everyone who carries out an occupation at work, including the self-employed, will be protected from risks to health and safety. Member States are required to ensure that employers provide their employees with personal protective equipment appropriate to the tasks assigned.

The Personal Protective Equipment for Construction legislation is designed to protect construction workers using tools, machinery, and equipment that may pose a risk to their health or safety.

The Personal Protective Equipment Directive 89/686/EEC requires the manufacturer to ensure that products meet specified essential requirements outlined in harmonized European standards EN 4511:1996 + A1:1998, EN 1621-1:2006+A2:2008 and EN 1621-2:2007+A1:2009.

Requirements for Physically Exposed Electrical Equipment (PEEE) 2014/35/EU & 2011/65/EU

The PEEE Directive 2014/35/EU harmonizes the laws of all EU Member States relating to electrical equipment designed for use in potentially explosive atmospheres (i.e., physically exposed equipment). It is a piece of European Legislation aimed at ensuring that consumer and industrial electrical equipment placed on the market comply with specific essential health and safety requirements.

For more information go here: Physically Exposed Electrical Equipment Directive 2014/35/EU.



Leave a Reply