Overview of CE Certification
The term "CE" implies that the producer or importers conform to European health, safety, and environmental protection standards. Keep in mind that CE is not a quality certification mark. The CE marking is mandatory for products sold in the European Economic Area, i.e. EEA, but is also affixed on products sold elsewhere that have been produced as per EEA standards. The CE mark implies that the items may be sold without any hassle in any part of EEA, irrespective of its nation of origin. It entails the CE Logo and, if applicable, the four-digit code of the certified body engaged with the conformity assessment procedure. CE stands for "conformité européenne", a French word for "European conformity."
In general, CE marking acts as a passport for a product intended to be sold European marketplace. It implies that the concerned product is in line with the essential health and safety requirements of all of the directives applicable to products.
Nations requiring the CE marking
CE marking is a legal compulsion for certain products intended for sale in the EU. The European Free trade Association, i.e. EFTA, & Turkey. The producers of items manufactured within these nations, & the importers of items made in other nations, affirm that CE-marked goods are produced per EU standards.
Following Brexit, the United Kingdom government launched UKCA marking as its equivalent conformance indicator & this is mandated for goods to be sold in Great Britain- although goods carrying CE marking can still be used until 1 Jan, 2023. As Northern Ireland has remained in line with the European Single market under Northern Ireland protocol, the CE mark remains a legal compulsion for products being sold in the market there. However, the UKCA marking might be utilized in tandem; it is not mandatory. Goods for sale in the UK may carry both marks.
As of 2019, CE marking was not mandatory for nations under the Central European Free Trade Agreement (CEFTA), but the members Serbia, Albania, Montenegro, North Macedonia have applied for EU membership & are using many of its standards within their legislation (as had most former Central European member nations of CEFTA that joined the European Union, before joining.
What type of documents are required to secure CE marking?
Technical file is a set of documents that showcase the product’s conformity with the CE-marking legislation. The documentation should reflect the applicable product safety requisites and encompass the design, manufacture, and operation of the product. Furthermore, it must be available for inspection by the concerned market surveillance authorities immediately after the product is placed in the marketplace located in EU region. Sometimes, the documentation might also need to be furnished to the Notified Body for review.
Technical documentation generally covers the following aspects:
- Technical description
- Circuit diagrams, drawings & photos
- Materials' bills
- Specifications and their applicability, EU declaration of conformity for critical components used
- Details pertaining to design calculations
- Test assessment or reports.
- EU declaration of conformity
Technical documentation can be prepared in any format (electronic or paper) & must be held for the duration of up to ten years after the manufacture last unit, & in most scenarios, reside in the EEA.
Procedural Approach to Secure CE certification in India
Based on the severity of the risk of the product, the CE marking is affixed by the manufacturer, who needs to ensure that their product stays in line with CE marking standards. In some scenarios, if a product entails lower risk, it can be self-certified, reflecting a declaration of conformity & affixing the CE mark to their product.
Self-certification is used only for items that entail lower risk for their use, & this is definitely foreseen in the Directive as per the product "category".To avail certification, the manufacturer must perform the following tasks:
- Inspect whether the item needs to have a CE marking. The product must stay in line with all directives that apply to the product.
- Opt for conformity assessment procedure from modules called out by product's Directive as per each category (severity of risk) involved. There are many modules relating to Conformity Assessment Procedures, but only a few involve self-certification. The majority of these procedures seek a "type Approval" and a Production conformity assessment by the Notified Body—the general modules of the certificate as shown below. A product typically seeks more than one procedure to be implemented.
- Module A – Internal production control.
- Module B – EC type-examination.
- Module C – Conformity to type.
- Module D – Production quality assurance.
- Module E – Product quality assurance.
- Module F – Product verification.
- Module G – Unit verification.
- Module H – Full quality assurance.
The severity of risk is specified by the category of each equipment. The higher the category, the greater the risk. After specifying the category, the producer, to secure certification, shall then apply the applicable procedure for a manufacturer, after confirming that the applicable modules for the product category have been applied, & the name & certification number of the notified agency involved in certification procedures (models).
Notified bodies engaged with the certification procedure are agencies that have been assigned by the member state (as per accreditation procedure) & have been notified via European Commission. These bodies act as an autonomous inspection agency and perform the procedure as enlisted in the applicable modules applied as per the relevant directives. A manufacturer can opt for any such body in any member state of the EU. Factually, the self-certification process entails the given stages.
Stage 1: Identify the applicable Directive (s)
The first step is to pinpoint whether the item needs to carry CE marking or not. Not all products seek CE marking in general, and only those items that come under the ambit of at least one of the sectoral directives need to be affixed with such marking.
Presently, more than twenty sectoral directives seek CE marking covering, but not confined to, items such as machines, electrical items, medical devices, pressure equipment, toys, PPE, construction products, & wireless devices.
Pinpointing which directive(s) might be applied, as there may exist more than one, entails a straightforward exercise of reading the scope of such Directive to determine which apply to the product (such as the "Low Voltage Directive," 2014/35/EU).
If the product does not comply with any of the sectoral directives, then such product does not require to be affixed with CE marking.
Stage 2: Pinpoint the relevant requirements of the Directive (s)
Each Directive entails distinct methods of manifesting conformity based on the classification of the product & its intended use. Every Directive consists of various 'essential requirements' that the product must comply with before being sold out in the market.
The most conducive way to express that such requirements have been complied with is by fulfilling the requirements of a relevant 'harmonized standard,' which present a presumption of conformity to these requirements, although the utilization of standards typically remains voluntary. Harmonized standards can be pinpointed by identifying the 'Official Journal' on the EU's official website or by heading over to the New Approach website launched by the EFTA & European Commission with the European Standardisation Organisations.
Stage 3: Determine an apt route to conformity
Apart from the self-declaration process, there are many 'attestation routes' to ensure conformity based on the Directive and classification of the product. Many products such as fire alarms, invasive medical devices, & Pressure Equipment, extinguisher systems, Lifts etc. have a mandatory requirement for the involvement of a third party, i.e. notified body.
There are various attestation routes as shown below:
- The product's assessment by the manufacturer
- A product's assessment by the manufacturer, with the supplementary requirement for mandatory audit of factory production control to be performed by the notified body.
- An assessment by the notified body, for instance, EC type test, with the requirement for factory production control audits to be performed by the notified body.
Stage 4: Conduct conformity assessment
When all the requisites have been identified, the conformity of the product as per essential requirements of the Directives requires to be assessed. This typically entails assessment &/or testing & may consist of a conformity evaluation of the product to the harmonized standard(s) pinpointed in step 2.
Stage 5: Prepare the technical file or documentation
Technical documentation or Technical file is one of the fundamental prerequisite for the manufacturer to secure CE marking. It needs to be prepared in line with EU directives and must entail details as mentioned above.
Stage 6: Make a declaration & affix the CE mark on the product
When the authorized representative is satisfied with the conformity assessment of the product, an EU declaration of conformity must be completed under the Machinery Directive. This is also applicable to partly completed machinery.
EU declaration of conformity generally manifests the following details:
- Manufacturer's name and address
- List of products along with their description and serial number
- List of relevant sectoral Directives that have been applied
- A statement reflecting that the concerned product complies with the applicable requirements.
- Name, designation, and signature of the person-in-charge
- Signature of the authorized personal
- Details relating to authorized representative with the EEA (where applicable)
- Additional Directive
After the completion of the EU declaration of conformity, the final step is to mark the product with the CE marking.
Key Functions performed by the Notified Body
Conformity assessment refers to service to manufacturers of product in an area of public interest. European nations are obligated to notify conformity assessment bodies located in their jurisdiction as per the principles cited in Decision 768/2008/EC Notified bodies:
In general, Notified Bodies;
- Are free to facilitate their conformity assessment services to any operator inside or outside the European Union
- May perform these undertaking in the territory of other EU nations or non-EU nations.
- Must operate in a transparent, non-discriminatory, autonomous and impartial manner
- Must employ the qualified individual to perform the conformity assessment as per the law(s) in question
- Must take suitable measures to ensues the confidentiality of the information secured during the conformity assessment
- Must be aptly insured to cover their professional undertaking undertakings, unless liability is assured as per national legislation of the notifying EU nation
- Must facilitate detail to their notifying authority, the market surveillance agencies, & other notified bodies
General Traits of the CE marking
- The CE marking must be affixed by the manufacturer or its authorized representative in the EU as per its legal format visibly, legibly, & permanently to the product.
- When a manufacturer affixes the CE mark on the product, it indicates that it complies with the essential requirements from all the directives applicable to its product.
For instance, for a machine, the machinery directives come into play, but often also;
- Low voltage directive
- EMC directive
- ATEX directive
- Other legal requirements
- When the machine manufacturers affix the CE marking, it assures that it has completed all the required assessments on the products to conform to all the requisites of applicable directives.
- CE marking has been launched by the COUNCIL DIRECTIVE 93/68/EEC of 22/07/1993 amending directives 88/378/EEC (safety of toys), 87/404/EEC (simple pressure vessels), 89/106/EEC (construction products), 88/378/EEC (safety of toys), 90/385/EEC (active implantable medicinal devices, 91/263/EEC (telecommunications terminal equipment, 93/42/EEC (medical devices), 89/392/EEC (machinery), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels), 73/23/EEC (electrical equipment designed for use within certain voltage limits), etc.
- The CE marking contain the initials "CE", both letters should adhere to same vertical dimension, which should not be less than 5mm.
- If the product's appearance does not permit for the CE mark to be affixed on the product itself, the same marking has to be put on the packaging or related documentation.
If a directive seeks the involvement of the third-party, i.e. notified body, in the conformity assessment procedure, its identification code has to be affixed behind the CE logo.
Leverage CorpBiz Expertise to avail CE Certification
It is evident from above that the process of securing CE certification is an onerous affair. It seeks on point identification, assessment, and evaluation of applicable directives. And there is no denying that on-field expertise is something you would require to serve that purpose.
CorpBiz experts can help the client to;
- Ensure accurate identification of applicable directives Prepare detailed and legit technical documents for the purpose of conformity assessment
- Pinpoint essential requirements of the product
Frequently Asked Questions
The CE marking indicates that the manufacturer take accountability for the product compliances with all relevant European health, safety, performance and environmental requirements.
CE marking enables an individual to legally sell their product in the European marketplace & declares that your product adheres to the relevant European Directives and Regulation
FDA approval means that the device is approved for use in all parts of the world, while the CE mark has restrictions, sometimes even within the EU. ... It is possible too that the FDA's strictness is seen as safer for consumers.
CE marking compliance refers to legal requirements in the European Economic Area countries. The CE marked products are allowed to sell in India, but they need to comply with the local standard like BIS or ISI.
Medical devices intended to be sold in the EU marketplace must have CE marking. The inclusion of such marking confirms that the medical device adheres to the applicable EU directives & enables the commercialization of the product in 32 European nations.
Machines that are supposed to be sold in European or UK marketplace must have CE marking under Machinery Directive before they become functional. The Directive applies to equipment and machines that are news and encompass machines that are modified or rebranded.
The declaration of conformity serves as a formal declaration made by the manufacturer's representative assuring that the product meets all the underlying requirement of safety directives underpinned by the law in question
Under CE certification, products adhering to minimal risk entail self-certification where the manufacturer prepares a Declaration of Conformity & affixes the CE mark to their product(s) in question.