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When designing a machine for customers in the European Economic Area (EEA), mechanical designers must ensure the equipment has full CE compliance. It is not optional; it is a legal requirement.
However, the landscape has changed significantly in recent years. With updated directives, the introduction of the UKCA mark post-Brexit, and the upcoming transition to the new Machinery Regulation, staying compliant is more complex than ever.
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What is CE Marking?
The CE marking stands for "Conformité Européenne" (European Conformity). By affixing this mark, the manufacturer asserts that the product meets all essential "Health and Safety" requirements of the relevant European legislation.
Figure 1: The CE mark acts as a passport for the EU market, while the UKCA mark is now required for Great Britain.
It acts as a "passport" for your product, allowing it to be sold freely within the EU Single Market. For machine designers, this isn't just about sticking a label on the machine; it is the culmination of a rigorous design and documentation process.
[Image of CE marking process flow chart]The "Big Three" Directives for Machinery
While there are many directives, mechanical engineers typically deal with three primary ones. You must verify which apply to your specific equipment:
- The Machinery Directive (2006/42/EC): The bible for mechanical design. It covers moving parts, guarding, and mechanical safety. (Note: This will be replaced by the new Machinery Regulation (EU) 2023/1230 starting in 2027).
- The Low Voltage Directive (2014/35/EU): Applies to electrical equipment operating between 50-1000V AC.
- The EMC Directive (2014/30/EU): Ensures your machine doesn't emit electromagnetic interference and is immune to external interference.
The 7-Step Path to Compliance
1. Identify Applicable Directives
Determine if your product falls under the Machinery Directive, LVD, EMC, or potentially ATEX (explosive atmospheres) or RoHS.
2. Determine the Conformity Assessment Route
Most standard industrial machinery allows for Self-Declaration (Internal Production Control - Module A). However, if your machine is listed in Annex IV of the Machinery Directive (e.g., table saws, presses, vehicle lifts), you generally must involve a Notified Body (a third-party testing lab) to type-examine the machine.
3. Conduct a Risk Assessment (The Core Step)
You cannot CE mark a machine without a documented Risk Assessment. The standard EN ISO 12100 outlines the iterative process of identifying hazards and reducing risks.
Figure 2: The iterative cycle of Risk Assessment (ISO 12100) is the foundation of the Technical File.
4. Apply Harmonized Standards
Designing to "Harmonized Standards" (like EN ISO 13849 for control systems or EN 60204-1 for electrical safety) gives you a "Presumption of Conformity." This is the safest legal route for a designer.
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5. Compile the Technical Construction File (TCF)
This is a "living document" that must be kept for 10 years. It must contain:
- General description and drawings (hydraulic, pneumatic, electrical).
- Calculations and test results.
- The Risk Assessment document.
- The Operator's Manual (in the language of the end-user).
6. Sign the Declaration of Conformity (DoC)
This is a legal document signed by a person with authority in the company (e.g., CEO or Engineering Director). It lists the serial number, model, and specific standards used.
7. Affix the CE Mark
The mark must be visible, legible, and indelible on the machine's nameplate.
Modern Update: The UKCA Mark
Following Brexit, Great Britain (England, Scotland, Wales) introduced the UKCA (UK Conformity Assessed) mark.
Important Note for Exporters:
If you sell into Great Britain, you likely need the UKCA mark. If you sell into the EU (or Northern Ireland), you need the CE mark.
Most manufacturers now apply both marks to the nameplate and issue two separate Declarations of Conformity to cover both markets effortlessly.
If you sell into Great Britain, you likely need the UKCA mark. If you sell into the EU (or Northern Ireland), you need the CE mark.
Most manufacturers now apply both marks to the nameplate and issue two separate Declarations of Conformity to cover both markets effortlessly.
Recommended Reading: CE Marking Handbook for Engineers
Original concepts based on work by Charlie Blackham, CE marking consultant.
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