How many times has a client approached us asking “Can you just do the CE for me?” often without realizing the full scope of the process or even fully understanding what the CE Mark actually represents.
In this article, we aim to clear the fog surrounding this topic. We will break down what this “notorious” CE marking really is, the steps required to achieve it, and why it is vital for the types of devices we work with every day.
What is the CE Marking?
Let’s start with the basics: the CE Mark is a mandatory requirement for a product to be sold freely within national and European markets. The legal obligation to subject a product to a conformity assessment falls on the manufacturer, importer, distributor or authorized representative.
The ultimate goal of this assessment procedure is to demonstrate that the product complies with the Essential Health and Safety Requirements (EHSRs) set out in the relevant European Directives. These requirements relate to the risks associated with the product’s use by consumers or workers, as well as its performance.
In practical terms, this results in a graphic logo that the manufacturer must affix to the product to attest, in an easily recognizable way, to its compliance with all applicable EU regulations.
Products that require CE Marking
The vast majority of products on the market require CE marking. Key categories include:
- gas appliances and boilers
- lifts (elevators)
- electrical equipment and tools
- weighing instruments
- construction materials
- personal protective equipment (PPE)
- medical devices
- toys
- power generators
- simple pressure vessels
- machinery
- batteries
- ATEX equipment (for explosive atmospheres)
- recreational craft
- electromagnetic compatibility (EMC)
- telecommunications terminals
The CE marking process
To legally affix the CE Mark, you must hold a CE Certificate or a set of test reports proving that the product has passed all mandatory tests (trials, inspections, etc.) required by the directives. This process in based on the manufacturer’s Declaration of Conformity, in which they formally state that the product meets all legal requirements and assume full legal responsibility for it.
Key steps for CE marking of machinery
Focusing on our core expertise at Stalab, here are the necessary steps for the correct CE marking of machines and partly completed machinery according to the Machinery Directive 2006/42/EC:
- Identification of legislation: pinpointing the specific directives and harmonized standards applicable to the machine type
- Compliance analysis: assessing the machine against the requirements of Directive 2006/42/EC and specific product standards
- Technical review: analyzing the electrical, pneumatic and hydraulic equipment
- Risk assessment: performing formal risk assessment and compiling the Technical File
- Instruction manual: drafting the user and maintenance manual
- Instrumental testing: performing on site or lab tests (Noise, Vibrations, Artificial Optical Radiation, EMF, Electrical Safety EN 60204-1 and EMC)
- Control systems analysis: verification of safety-related parts of control systems (PL&SIL)
- Validation: validating safety circuits according to UNI EN ISO 13849-1:2023 and UNI EN ISO 12849-2:2013
- Software validation: validating safety-related software
- Declaration of conformity: issuing the final legal document
- CE Plate: affixing the physical nameplate to the machine
CE marking is not a “one-off” task that can be improvised; it is a rigorous and structured process that demands strict adherence to regulations and a series of detailed evaluations. While it may seem complex, it is the foundation of product safety and quality, protecting both the consumer and the end-user.
Following the correct path is essential, not just for legal compliance, but for your reputation and reliability in the global market.
