Affixed on many categories of products, including medical devices, electrical and electronic equipment, machinery, equipment used in hazardous location etc., CE marking is mandatory if you want to sell your product in the EU.
This blog serves as a guide for those manufacturers who want to launch their electronics product in the European market and need an understanding into CE marking for electronic equipment.
Before we get into the specific details and requirements, here are few things of note that manufacturers should know.
First, the CE marking process is independent of the origin of the product. Your product could be manufactured and assembled in Australia, China or in the Europe itself – if you are intending to sell it in Europe it must be CE marked.
Second, to apply for the CE marking process, the manufacturer either:
- Needs to be European or,
- Needs to own an official department in the EU or,
- Needs to be represented by an official agent who would be willing to share the liability for the marking and hold the Declaration of Conformity on his behalf.
The process of getting your electronics product CE marked, can be divided into six basic steps.
- Determining the directive that applies to your piece of electronic equipment.
- Determining the standards and requirements that your product needs to conform with.
- Selecting a conformity assessment route.
- Getting the product tested to check its conformity with the established standards and requirements.
- Compiling a technical file
- Drawing up Declaration of Conformity and getting your product CE affixed.
Next, we will briefly look at the details of each of the step.
Directives for Electronic Equipment
Every product category is governed by a specific set of directives. In case of electronic equipment, the most commonly applicable directives are:
- EMC Directive
- Low Voltage Directive
- Radio Equipment Directive
- RoHS Directive
- Waste from Electrical and Electronic Equipment Directive
Standards and Requirements Entailing the Directives
Each directive contains standards and requirements that will vary with one type of electronic equipment to another. This is where you will determine the standards and requirements that your product needs to conform with.
One way of doing that is to refer to your competitor’s data sheet and the public records as made available by the European Union. If this process appears too cumbersome and tedious, you can consult an international homologation service provider that deals in CE certification services.
Establishing the Need for a Notified Body
In some cases, you will need a notified body which would serve as a conformity assessment authority, while in other cases you won’t. For example, for radio transmitters you usually need to seek the services of a notified body.
The conformity assessment route you opt for depends on the type of electronics product you intend to sell.
Testing Your Product
After you have selected a conformity assessment route, you will then need to get your product tested to validate that it complies with the established requirements.
In case where you opt for a self-conformity approach, you can test your product in-house or send it to a third-party lab. Where a notified body is heading the conformity assessment procedure, the organization itself would handle it.
Technical Dossier – It’s VERY Important to Have One
The CE mark is not the evidence of compliance; it is only the mark of compliance. Your technical dossier serves as the evidence of compliance. It would contain details about your product’s design, the results of the test, the details of the testing facility, the purpose of your product and statement of conformity from the notified body (if involved in your case).
Declaration of Conformity and Affixing the CE Mark
Once you have all the evidences in place that your electronics product complies with the directive’s standards and requirements, you can then draw up a Declaration of Conformity. The document serves as an official statement for your evidenced compliancy.
Following that, you can then stick the CE label on your electronic equipment—it’s ready for Europe.
Got anything else to ask about the CE marking process for your electronic equipment?
Reach out and we will make sure all your queries are facilitated promptly. We can also help you in getting your electronics product CE marked so that you can start selling it in the European market quickly. We look forward to serving you!