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.
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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 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:
- 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:
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:
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;
General Traits of the CE marking
For instance, for a machine, the machinery directives come into play, but often also;
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;