The CE Marking Process Step by Step.
Phase 1: Identify the applicable EU Directive(s) and harmonised standards
The EU Directive(s) applicable to the product that is intended to the EEA market should be identified, so as to establish whether the product requires CE marking or not.
The product should then is assessed for conformity to the essential requirements in the applicable directive(s) that covers both the design and production phases of that product.
The manufacturer then identifies and implements harmonized European standards that are applicable to the product that is intended for CE marking.
Phase 2: Identify the conformity assessment procedure
Conformity assessment consists of a process that the manufacturer is responsible for carrying out, to demonstrate that the applicable requirements in the EU directives have been fulfilled. This process is laid down under the Decision No 768/2008 EC.
There are eight different conformity assessment procedures called modules (named with letters A to H), some of which have variants. The manufacturer shall choose one or two conformity assessment modules to ensure directive(s) compliance to cover both design and production phases. The distinct conformity Assessment modules and their descriptions are outlined below.
Phase 3: Conduct a conformity assessment of the product
Each of these modules lay down distinct responsibilities on the manufacturer and determine various routes of conformity depending on the applicable directive(s) and risk classification of the product. In essence, conformity assessment routes include:
- Assessment of the product by the manufacturer, without third party involvement. This option is applicable in case of low complexity in design and production mechanism and thus the product carries low risk for the public interest (e.g. Module A).
- Assessment of the product by the manufacturer, together with additional requirement for mandatory audits carried out by a notified body chosen by the manufacturer. Some such modules are based on quality assurance techniques derived from the EN ISO 9000 and EN ISO 9001 standards (e.g. modules D, E and H). This applies for products with more design complexity and increased public risk when in use.
- Assessment of the product conducted by a notified body involving services such as product testing and type examination certification issue, together with mandatory audits carried out by a notified body chosen by the manufacturer (e.g. module H). This applies for products where design is complex and risk to user’s safety is very high.
Phase 4: Compilation and maintenance of technical documentation
Following, the achievement of a positive conformity assessment result for your product a technical file needs to be compiled. This consists of a range of technical documentation (e.g. technical descriptions, bills of materials, specifications, test reports, instructions for use and EU declaration of conformity (EU DoC) )that verifies compliance to the EU directive(s) with respect to the design, development and production of the product.
The technical documentation (including the EU declaration of conformity) must be kept for 10 years after the last item of the product has been placed on the market.
Certain directives (such as the council directive 93/42/EEC for medical devices as amended by Directive 2007/47/EC), has a requirement that the manufacturer appoints an authorized representative in the European union, that is in a position to provide the technical file on request of a market surveillance authority.
In addition, certain directives specify that if the manufacturer does not have a registered place of business in the EEA, the name of address of the authorized representative in the European Union should be present on the label, outer packaging and product instructions. 
Phase 5: Preparation and maintenance the EU Declaration of conformity
The manufacturer or authorized representative established in the EU must complete and sign an EU declaration of conformity which assumes responsibility for the compliance of the product to the applicable EU directive(s). In terms of content, this declaration contains a list of directives and harmonized European standards that the product is conforming to, product identification, manufacturer and authorized representative name, address and approval.
Phase 6: Product registration in the EU
Certain classes of products such as medical devices, require to be formally registered in EEC and then there is a certificate of registration issued.
Phase 7: Affix CE mark on product and/or packaging
CE marking must be affixed to the product in a legible and indelible manner or to its packaging if it is not possible on account of the nature of the product. Also, the CE marking must be affixed to any documentation accompanying the product. CE marking should not be affixed on the product in advance of conformity assessment procedure completion and as a result it is expected to be at the end stages of the production process. When the conformity assessment procedure requires a notified body to be involved in the production phase, the identification number of the notified body must accompany the CE marking.
 Quality management systems — Fundamentals and vocabulary
 Quality management systems — Requirements
 Directive 2007/47/EC, 05 September 2007
 Directive 2007/47/EC, 05 September 2007