Editing CE marking (section)

==Self-certification==
{{more citations|section|date=February 2025}}
Depending on the level of [[risk]] of the [[Production (economics)|product]], the CE marking is affixed to a product by the [[Manufacturing|manufacturer]] or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products that have a minimal risk for their use, and this is clearly foreseen in the relevant directive and regulation according to the product "category". In order to certify, the manufacturer must do several things:{{cn|date=February 2025}}

# Investigate whether the product needs to have a CE marking. The product must conform to all [[Directive (European Union)|Directives]] and [[Regulation (European Union)|Regulations]] that apply to the product.
# Choose the [[conformity assessment]] procedure from the modules called out by the directive or the regulation for the product according to each category (level of risk) involved. There are several modules available for the Conformity Assessment Procedures, but only a few of them involve self-certification. The most of these procedure require a "type Approval" and a Production conformity assessment by a [[Notified body|Notified Body]]. All procedures (modules) of certification are as listed below which are derivered from Article 5.1.7 of "Blue Guide".<ref name="Blue Guide" /> A product normally needs more than one procedure (Module) to be implemented:
:* Module A  – Internal production control.
:** Module A1 – Internal production control plus supervised product testing
:** Module A2  – Internal production control plus supervised product checks at random intervals
:*  Module B  – EU type examination.
:*  Module C  – Conformity to EU type based on internal production control
:**  Module C1 –   Conformity to EU type based on internal production control plus supervised product testing
:**  Module C2 –  Conformity to EU type based on internal production control plus supervised product testing
:*  Module D  – Conformity to EU type based on quality assurance of the production process.
:**  Module D1  – Quality assurance of the production process.
:*  Module E  – Conformity to EU type based on product quality assurance
:**  Module E1 –  Quality assurance of final product inspection and testing
:*  Module F  – Conformity to EU type based on product verification.
:**  Module F1 -  Conformity based on product verification.
:*  Module G  – Unit verification.
:*  Module H  – Full quality assurance.
:**  Module H1  – Full quality assurance and Design Examination.

The level of risk is defined by the "category" of each equipment. The higher the category, the higher the risk. After defining the category, the manufacturer, in order to obtain certification, shall then apply the relevant procedures for the specific category of the product or choose the relevant procedures for a higher-category product. The manufacturer, after insuring that the relevant modules for the product category have been applied, will affix the [[File:Conformité Européenne (logo).svg|16px|alt=CЄ|link=|class=noviewer skin-invert-image]] mark and draw up a Declaration of Conformity. The Declaration of Conformity contains a description of the product, the directive(s) and regulation(s) applied, the product category for each directive or regulation, the module chosen, and the name and registration number of the notified body involved in certification procedures (models).

Notified bodies involved in certification procedures are organizations that have been nominated by a [[Member state of the European Union|member state]] (according to an [[accreditation]] procedure) and have been notified by the [[European Commission]]. These notified bodies act as Independent Inspection organizations and carry out the procedures as listed in the relevant Modules applied as stated by the relevant directives and regulations. A manufacturer can choose any notified body (notified for the certain directive or regulation and relevant Modules) in any Member State of the European Union.

In reality, the self-certification process consists of the following stages:

'''Stage 1: Identify the applicable norm(s)'''

The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral norms (directives and regulations) requiring CE marking. There are more than 20 sectoral product norms requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.

Identifying which norm(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each norm to establish which apply to the product (Such as the "Low Voltage Directive," 2014/35/EU). If the product does not fall within the scope of any of the sectoral norm, then the product does not need to bear CE marking (and, indeed, must not bear CE marking).

'''Stage 2: Identify the applicable requirements of the norm(s)'''

Each norm has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive or Regulation has a number of 'essential requirements' that the product has to meet before being placed on the market.

The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable 'harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonised standards can be identified by searching the 'Official Journal' on the European Commission's website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.

'''Stage 3: Identify an appropriate route to conformity'''

The process is not always a self-declaration process, there are various 'attestation routes' to conformity depending on the Directive or Regulation and classification of the product. Many products (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a "notified body".

There are various attestation routes which include:

*An assessment of the product by the manufacturer.
*An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party.
*An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.

'''Stage 4: Assessment of the product's conformity'''
[[File:Consumer Reports - product testing - headphones in anechoic chamber.tif|thumb|Example of safety product testing: headphones in [[anechoic chamber]].]]

When all of the requirements have been established, the conformity of the product to the essential requirements of the norm(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.

'''Stage 5: Compile the technical documentation'''

Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.

Technical documentation will usually include:

*Technical description
*Drawings, circuit diagrams and photos
*Bill of materials
*Specification and, where applicable, EU declaration of conformity for the critical components and materials used
*Details of any design calculations
*Test reports and/or assessments
*Instructions
*EU declaration of conformity
*Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).

'''Stage 6: Make a declaration and affix the CE marking'''

When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable norms, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation.<ref>{{Cite web|date=14 October 2021 |title=Declaration of Conformity Guidance & Template |url=https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm |url-status=live|access-date=9 December 2021 |website=Your Europe |archive-url=https://web.archive.org/web/20190930141056/https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm |archive-date=30 September 2019 }}</ref>