The European Commission outlines a clear 7-step process for obtaining CE marking. Understanding each step helps exporters avoid costly mistakes and delays.
Step 1: Identify Applicable Directives
Commercial equipment typically falls under multiple directives. The most common for industrial machinery include:
- Machinery Directive 2006/42/EC (being replaced by Regulation (EU) 2023/1230 from January 2027)
- EMC Directive 2014/30/EU (Electromagnetic Compatibility)
- Low Voltage Directive 2014/35/EU
- RoHS Directive 2011/65/EU (Restriction of Hazardous Substances)
Step 2: Determine Conformity Assessment Procedure
Not all products require third-party testing. Many commercial equipment items can use self-declaration (Module A), where the manufacturer assesses conformity internally. However, high-risk machinery listed in Annex I Part A of the new Machinery Regulation requires involvement of a Notified Body—an accredited third-party organization.
Step 3: Compile Technical Documentation
The technical file is the backbone of CE compliance. It must demonstrate how the product meets essential requirements through design documentation, risk assessments, test reports, and manufacturing records [5].
Step 4: Draw Up Declaration of Conformity (DoC)
The DoC is a legally binding document where the manufacturer (or importer, if rebranding) declares the product complies with all applicable directives. It must include:
- Manufacturer/importer name and address
- Product description and serial number
- List of applicable directives and standards
- Date and signature
Step 5: Affix CE Marking
The CE mark must be visible, legible, and indelible. Minimum size is 5mm, and it must be placed on the product, packaging, and accompanying documentation [7].
Critical Deadline: The new Machinery Regulation (EU) 2023/1230 becomes mandatory on January 20, 2027, with no grace period. Products placed on the market after this date must comply with the new regulation, not the old directive
[3].
Steps 6-7: Post-Market Surveillance and Documentation Retention
Manufacturers must maintain technical documentation for 10 years after the last product is placed on the market. National authorities can request this documentation at any time, and failure to produce it can result in product recalls, fines, or market bans [5].