6 Steps How to Get CE Marking for Your Product?

Full CE Certification Guide- 6 Steps How to Get CE Marking for Your Product in 2018?

Everyone who deals with CE Marking Certification services has one important wish. Whether he or she is CE Marking newcomer or CE Certification expert, they want to find out how to Get CE Marking for Your Product. The truth is, getting CE Certification turns out to be a real headache, especially after the new update. But fear not, EU-CERT is here to bring you a special gift as we ring in the new year. Make sure to carefully read this entire guide and follow 6 steps of the advice given to secure the CE Mark Certification. Success will be inevitable if you follow EVERY given recommendation.

Six Steps to Get CE Marking Certification

Here are Top 6 Steps To Get CE MarkingCertificationfor Your Products

  1. Find the CE marking directives that apply to your Equipment
  2. Know the essential requirements for your Equipment
  3. Determine if you need third-party certification
  4. Assess Equipmentconformity
  5. Create and maintain technical documentation
  6. Declaration of Conformity and affixing the CE Marking

Introduction to EU-CERT

CE Certification can be confusing, costly, complex, and can take up a lot of a company’s precious time.

EU-CERT Certification Body helps companies navigate the complexities of international markets. EU-CERT Certification Body provides Indian companies with on the ground insight, and an unbeatable network of contacts in more than 40 cities worldwide. The 6 steps of this EU-CERT bring together insight on CE marking certification from experts and as well as key European Union resources.

What is the CE Marking / CE mark/ CE Certification?

The CE Marking below is a sign that a manufacturer sees description below affixes to an equipment so that it can be sold in Europe. The CE mark is necessary for Equipment’s which fall under one of 24 European directives. The CE Marking means that the manufacturer takes responsibility for the compliance of an equipment with all applicable European health, safety, performance and environmental Needs. CE Marking stands for “ConformitéEuropéenne”, the French word for European conformity.

The CE Marking is required in all 27 member states of the European Union, as well as Iceland, Norway, and Liechtenstein. Switzerland accepts the CE Marking for some Equipment’s and Turkey actually requires that many types of Equipment which are CE marked.

Definition of the manufacturer:

The normal legal person with responsibility for the design, manufacture, packaging, and labeling of a product before it is placed on the market under its own name. The bottom line: CE Certification provides entry to a market of over 400 million customers.

CE marking is not like other certification marks.

EU-CERT Laboratories marks, for example, can only be used when those organizations have determined that product meets applicable standards. European organizations do not grant authorization to use the CE Marking as it is not owned by any specific body. The manufacturer is answerable for its full use.

The manufacturer, whether established inside or outside the European Union, is ultimately responsible for affixing the CE Marking and is also answerable for its full use. The manufacturer established outside the European Union may appoint an authorized representative established in the European Union to act on his behalf. CE Certification is about more than affixing a sign to Product.

Following the 6 steps to learn about the CE Certification process.

Step 1

Find the CE marking directive(s) that applies to your Equipment.

How do you know if your Product requires a CE Marking Certification? The 1st step is to see if your Equipment is covered under one or more of the 24 CE Marking directives below. If your Equipment falls under any of these directives, it has a requirement to be CE marked.

Here are 24 CE Marking Directives:

Product CategoryDirective Number
Active Implantable Medical Devices90/385/EEC, 93/42/EEC, 93/68/EEC, 2007/47/EC
Appliances Burning Gaseous Fuels2009/142/EC (ex 90/396/EEC)
Construction Products 89/106/EEC, 93/68/EEC
Cableway Installations to Carry Persons2000/9/EC
Ecodesign for Energy-related Products2009/125/EC
Electromagnetic Compatibility2004/108/EC
Equipment Explosive Atmospheres94/9/EC
Explosives for Civil Uses93/15/EEC
Hot-water Boilers (liquid or gaseous fuels) 92/42/EEC, 93/68/EEC, 2004/8/EC, 2005/32/EC
In Vitro Diagnostic Medical Devices98/79/EC
Low Voltage2006/95/EC
Lifts95/16/EC
Measuring Instruments2004/22/EC
Medical Devices93/42/EEC, 98/79/EC, 2000/70/EC, 2001/104/EC
Machinery 2006/42/EC
Noise Emission for Outdoor Equipment2000/14/EC
Non-automatic Weighing Instruments2009/23/EC (ex. 90/384/EEC)
Personal Protective Equipment89/686/EEC, 93/68/EEC, 93/95/EEC, 96/58/EC
Pressure Equipment97/23/EC
Pyrotechnic Articles2007/23/EC
Recreational Craft94/25/EC, 2003/44/EC
Radio Equipment and Telecommunications Terminal Equipment99/5/EC
Toy Safety2009/48/EC 88/378/EEC, 93/68/EEC
2007/47/EC 

What is a directive?

A directive is a lawmaking act of the EU which requires member states to comply their national laws to get a specific result that is harmonized with European Union rules in this area.

For example, the European Union directive for Equipment which falls under the electromagnetic compatibility category directive number 2004/108/EC calls for member states to ensure that electrical products that fall under this category meet certain needs:

Be ready for this: 

Deciding whether your Equipment/Product/Device falls under one or more directives can be difficult. For example, if you manufacture electronic packaging products with a conveyer belt, various directives will impact on your Products. If you want to know which directives apply, you will have to go through each of the 24 directives Equipment/Product/Device averages is sometimes found in an extension. There is no reference tool or database that lists which directives might be applicable to certain Equipment /Products/Devices. A EU-CERT Certification Experts can help you navigate these complexities.

Next step.

Once you have figured out if your Equipment/Product/Device falls under one or more directives, it is time to assess if your Equipment/Product/Device confirms to the applicable directives and, if not, how to get conformity?

Step 2

Know the important requirements for your Equipment/Product/Device

Each directive details what the European Union legally requires your Equipment/Product/Device to be compliant. These are officially referred to as important requirements in the directive. These requirements are very general in nature. The directives do not detail how to design an Equipment/Product/Device in a way that it meets the important requirements.

Harmonized standards

The European Commission often series mandates to European organizations European Committee for Standardization, European Committee for Standardization and European Telecommunications Standards Institute develop standards which are harmonized with the important needs of the directives. To see if a harmonized standard exists for your Equipment/Product/Device, A Equipment which conforms to harmonized standards is consider complying with the important needs of applicable directives.  For information about the content and availability of these harmonized standards, Search the following organizations on Google:

  1. European Committee for Standardization (CEN )
  2. European Committee for Electrotechnical Standardization (CENELEC )
  3. European Telecommunications Standards Institute (ETSI )

Other Standards

In many cases, manufacturers may confident on standards other than harmonized standards in order to display compliance with the important requirements in the directives. One Makeableleaving out to this rule is the Construction Products Regulation soon to change the Construction Equipments Directive which makes the use of harmonized standards necessary.

European Commission (EU) guidelines

The European Commission usually provides detailed guidelines on the application of particular directives, including details on the interpretation of the important Needs of the directive. While these guidelines do not have legal value only the legitimate text of the directive does, they are usually written in consultation with Member State authorities that apply the directives.

Be ready for this:

A harmonized standard can cost anywhere from 300 to 1500 Euros. These may be costly but could be worth the investment. While a manufacturer does not need to buy these documents to meet the important requirements of the directive, European authorities generally use them to decide whether an Equipment/Product/Device meets the important requirements. Working from the same document can help you to avoid potential technical disputes over whether your Equipment/Product/Device meets the important requirements of the directive. Again, important requirements are generally vague – leaving lots of room for technical interpretation.

For Example:
Below is an excerpt from a table of harmonized standards for construction products, though not all tables have the same format:

Harmonized standards for construction products

ESOReference and title of the harmonized standard
(and reference document)
Reference of superseded standardDate of applicability of the standard as a harmonized European standardDate of the end of the co-existence period Note 4
CENEN 1:1998
Fluid oil stoves with vaporizing burners
01/01/2008 01/01/2009 
EN 1:1998/A1:2007Note 301/01/2008 01/01/2009 
CENEN 40-4:2005
Lighting columns – Part 4: Requirements for reinforced and prestressed concrete lighting columns
01/10/2006 01/10/2007 
EN 40-4:2005/AC:200601/01/2007 01/01/2

 

Column 1: The European Standards Organization (ESO), is the group answerable for the adoption and publication of European Union standards.  For the construction products above, the European Committee for Standardization (CEN) is the author.

Column 2: Refers to the title of the harmonized standard and its reference document

Column 3: The reference to the previously upheld standard, if applicable.

Column 4: The date the standard came into effect.

Column 5: The date after which the old standard can no longer be used.

Next step.

Once you have classified the important requirements in the directives and harmonized standards applicable to your Equipment, you need to determine whether your Equipment meets the applicable requirements and whether you need to have a conformity assessment body test and certify your Equipment/Product/Device to make secure that this is the case.

Step 3

Decide if you need third-party assessment

Some directives require that Equipment/Product/Device be tested and certified by a third-party organization in order to ensure their conformity with applicable important requirements. Whereas these organizations are known worldwide as conformity assessment bodies, they are also known in Europe as notified bodies. If applicable directives do not need the use of notified bodies, manufacturers may build their own in-house facilities to evaluate their Equipment/Product/Deviceconformity.

An NB is an entity authorized by European authorities to assess an Equipment/Product/Deviceconformity to the important requirements set out in the applicable directives. A notified body also conducts an audit to make sure manufacturers have completed steps 1 and 2 – that they have verified the directives and important requirements applicable to their Equipment/Product/Device.

Some directives signify that a manufacturer must use a notified body for some Equipment/Product/Device. These directives include the Medical Devices Directive, the Equipment/Product/Device, and the Pressure Equipment Directive, Protective Systems in Potentially Explosive Atmospheres directive, the Appliances Burning Gaseous Fuels directive, and the Simple Pressure Vessels directive.

Additional directives do not apply that manufacturers rely on the notified body if the manufacturer uses a harmonized standard see step 2 to regulate conformity with applicable important requirements. On the other hand, the use of a notified body is required for some of the Equipment/Product/Device covered under these directives if a manufacturer does not use the applicable harmonized standard. These directives include the Machinery Directive and the ToySafety directive.

The European Union has reduced the number of Equipment/Product/Device that requires notified body assessment. The LVD Low Voltage directive, for example, does not need the use of the notified body. European authorities are to a greater extent putting the onus on manufacturers to prove their Equipment/Product/Device are compliant.

Step 4

Assess Equipment/Product/Deviceconformity

How do you understand that you areEquipment/Product/Device complies with the essential requirements in the applicable directives? You will have to test and document that you areEquipment/Product/Device actually conforms. Each directive outlines which conformity assessment procedures – also referred to as modules – a manufacturer can undertake. There are eight conformity assessment modules. The applicable directives outline which modules implement for a specific Equipment/Product/Device category.

Module A: Internal production control
Module B: EC type examination
Module C: Conformity to type
Module D: Production quality assurance
Module E: Equipment/Product/Device quality assurance
Module F: Equipment/Product/Device verification
Module G: Unit verification
Module H: Full quality assurance (EN ISO 9001)

Using module B as an example, the chart below gives an overview of the tasks that a manufacturer and the NB must carry out, as well as the tasks that the manufacturer can delegate to an authorized representative. Mostly, the closer an Equipment/Product/Device gets to Module H, the more essential notified body becomes.

Module: B

Manufacturer -Create technical file regarding the design, manufacture, and operation of the Equipment/Product/Device

The manufacturer or authorized representative:

  • Applies for the EC type-examination
  • Places at the disposal of the NB one or more specimen), which is representative of the production envisaged
  • Informs the NBof all modifications to the approved Equipment/Product/Device
  • Keeps the technical file, including a copy of the EC type-examination certificate, at the disposal of the surveillance authorities

NB (Notified body):

  • Make sure, by performing or having performed examinations and testing, that the sample meets the applicable provisions and is manufactured in accordance with the technical file
  • Issues an EC type-examination certificate
  • Keeps a copy of the certificate and a record of other suitable technical details
  • Communicates to the other NB the relevant details concerning the EC type-examination certificates

These eight procedures can be boiled down to two approaches:

Assessment of conformity by the manufacturer: 

The manufacturer can hire a service provider for their approach to testing facilities but will pay commonly for testing or another part of conformity assessment, not consulting and certification, which is also what a notified body is contracted to do. A company can determine conformity of Equipment/Product/Device by itself if it has the mandatory facilities to test it is Equipment. This procedure is much less expensive.

  • Assessment of conformity by a notified body: The manufacturer is necessary to use notified body to check conformity and certify its Equipment/Product/Device, but it finally remains responsible for their conformity with European UnionimportantNeeds.Conformity assessment to the European directives for CE Certification may exist different activities, including Equipment/Product/Device testing, visual inspection, risk analysis as well as a review of Equipment labels and instructions. Typical steps which may be involved in the assessment of conformity include:
  • Review of the technical File related to the design, manufacture and or operations of the Equipment/Product/Device
  • Testing of one or more specific aspects of each Equipment/Product/Device, or of a sample of the Equipment, or of a representative specimen of the Equipment.
  • Assessment of the production quality systems of the manufacturer and
  • Ongoing verification of Equipment/Product/Device unit conformity.

Be prepared for this:

Many directives admit the manufacturer to select among different conformity assessment procedures for the same Equipment/Product/Device. Knowing all your options can production of lab significant savings in time and money.

Next step.

Your Equipment/Product/Device has been tested and meets all related European Community standards. Now, your technical file must be in order.

Step 5

Build and maintain Technical File

All CE Certification directives set an obligation for the manufacturer to Build and make available technical File containing details that demonstrate the Equipment/Product/Device conforms to the needs of the directive.

Technical Files relevant to a CE marking Equipment/Product/Device must be kept for at least 10 years from the last date the Equipment was manufactured, except that the directive provides for a later date. The technical File must be provided on demand to the implementation of rule authorities, frequently within short timelines. The technical File requirements to be kept up to date, particularly when the Equipment is modified or is subject to updated conformity assessment methods.

Translation

Although several of the CE Certification directives and European national laws impose that user details be translated into the official languages of the countries where they are sold, the rest of the technical Filecan be maintained in any European Union language including English or French.

Location of the Technical File

European Union law does not need that the Technical File be located in Europe. The situation is different for the Declaration of Conformity See step 6. However, European Union importers must make secure that the exporter provides that TechnicalFileto European Union enforcement authorities. Furthermore, European Union importers or distributors marketing Equipment/Product/Device under their own names are needs to have a copy of the complete technical file.

Examples

TechnicalFileneeds for the LVD (Low Voltage Directive)

  • Information of the design, manufacture, and operation of the electrical product in so far as these details are needed to check the conformity of the electrical Product/Equipment/Device with the needs of the directive.
  • A common description of the electrical Product/Equipment/Device.
  • Design and manufacture drawings plus diagrams of components, subassemblies, circuits, and etc…
  • Write and explanations needed to know the above-mentioned drawings and diagrams plus the operation of the electrical Product/Equipment/Device.
  • A list of the standards used, in full or in part, and a description of the solutions employed to meet the safety aspects of this directive when harmonized standards have not been applied.
  • The results of design calculations and of checks carried out, and etc….
  • Testing reports either by the manufacturer or a third party.

TechnicalFileRequired for the EMCD (Electromagnetic Compatibility Directive)

  • An identification of the Equipment/Product/Device covered by the technical file. This identification should allow unambiguously linking between the technical file and the Equipment.
  • A common description of the apparatus. The number of details required will depend on the complexity of the equipment with a purpose. as apparatus may be completely defined in one line whereas more complex apparatus may need a full description a picture may be included.
  • If European harmonized standards have been applied then proof of compliance is required. At a minimum, this will be a dated list of the European harmonized standards applied and the results get on their application.
  • If European harmonized standards have not been applied or have been applied only in part, then a description of the steps taken to meet the mandatory requirements – an EMC Assessment described in Annex II of the directive – must be included. The documentation includes testing reports, design calculations made, examinations carried out and etc…
  • If a manufacturer is using the procedure of Annex III of the EMCD, then the NB statement shall be included.

Step 6

Declaration of Conformity and affixing the CE Marking

The document confirms compliance with CE Certification directives is the Declaration of Conformity. The Declaration of Conformity is an acknowledgment by the manufacturer that they are answerable for the compliance of its Equipment/Product/Device with the applicable directives.

This document is the manufacturer’s sole responsibility, and the establishment of the Declaration of Conformity is a legal responsibility.

The declaration should be available to authorities at the European Union point of entry. Opposite to the fullTechnicalFilewhich does not important requirements to be shared with importers and distributors in some cases See step 5, the Declaration of Conformity should be made available to European Uniondistributors, who may need to provide it to national authorities immediately upon request.

The Declaration of Conformity is mostly one-pager that includes the following:

  • Who are you?
  • What Equipment/Product/Device it refers to?
  • What directives are involved?
  • Which standards have been used?
  • Where can test results be found?
  • Who is responsible for your company?

Affixing the CE Marking

The CE Marking must be affixed to all new Equipment/Product/Device, whether manufactured in the Member States or in third countries to used and second-hand Equipment imported from third countries and to essentially modified Equipment that is subject to directives as new Equipment.

Directives may exclude the application of the CE Marking on certain Equipment, even if the directive otherwise applies to the Equipment/Product/Device. These particular exceptions vary from directive to directive.

The CE marking certification may not in principle be affixed just before the conformity assessment procedure has been finished to make secure that the Equipment/Product/Device complies with all the provisions of the related directives. This will commonly be at the end of the production phase. However, if the CE MarkingCertificationforms an inseparable part of the Equipment, or of a component, for example by stamping or casting, the mark can be affixed at any other stage of the production phase, provided that the conformity of the Equipment is verified as relevant throughout the production phase.

The CE Certification shall, as a rule, be affixed to the Equipment/Product/Device to its data plate. However, it may instead be affixed to the packaging or to the accompanying documents if:

  1. Affixing the CE Mark is impossible;
  2. It is not achievable under reasonable technical or economic conditions, where the minimum dimensions could not be respected.
  3. It could not be ensured that the CE Certification was visible, legibly and indelibly affixed manufacturers may not do so on purely aesthetic grounds.

The CE Certificationexistsof the letters CE sometimes followed by the identification number of an NB, as below. The identification number of the Notified bodies is added only when that Notified body has been involved in the production phase of the Equipment/Product/Device.

Sometimes various NB is involved in the production phase, where more than one directive is applicable. In these situations, various identification numbers follow the CE Certification.

Be ready for this:

The CE Certification must be without difficulty seen and accessible for all parties. It could, for instance, be affixed to the back or underside of an Equipment/Product/Device. A minimum height of 5 mm is required to make secure that it is legible. It shall also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces. For example, some Equipment standards use a rub testing with water and petroleum spirits. However, this does not mean that the CE Certification must form an integral part of the Equipment.

If you are Searching for secrets about CE certification, Check Here top 12 secrets about CE marking certification of electrical and electronic products

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Full CE Certification Guide- 6 Steps How to Get CE Marking for Your Product in 2018?


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