CE Marking... yes or no?
The first question many manufacturers ask before starting a CE marking consulting is: “Does my product need to be CE marked?"
To this question, one would expect an immediate "YES" or "NO", but the answer cannot be so simple. Precisely for this reason, the so-called “Identification of the Applicable Legislation”, which also answers this question, is a phase to be carried out compulsorily by law in the context of CE marking.
In other words, regardless of whether your product requires CE marking or not, an initial Identification of the Applicable Legislation must always be carried out.
Moreover, even if the initial Identification of the Applicable Legislation reveals that your product does not have to be CE marked, in any case it must comply with the obligations of the General Product Safety Directive (GPSD), so it is always good to rely on a consultant to have assistance about your product safety. The consultant, depending on the case, will provide you with support for the CE marking (if the answer is "CE marking yes") or for the general safety of the product (if the answer is "CE marking no").
Why it is so complicated to answer?
If you are wondering why it is so complicated to answer an apparently simple question, the answer is in the CE marking legislation. On the same legislation you can find the answer to the question, but you should know that merely reading it is not enough.
Reading and interpreting the legislation on CE marking is in fact quite time-consuming, and each directive or standard has its own "language". In each initial section of these directives there are some definitions that are valid for the single directive in which they are mentioned, and it seems as if some of these definitions are the same in several directives. But beware! Some of the terms indicated in the definitions could actually be the same (for example “product”, "manufacturer", "importer", “distributor", etc.). The meaning, however, could change substantially for each directive. Therefore, in order to read each directive, one must first read the definitions of the directive itself, without confusing them with the definitions provided by other directives or with the "common sense" of the terms indicated.
Once the obstacle of definitions has been overcome, in order to answer the question "CE marking yes or CE marking no?", It will be necessary to check the respective scope of application for each directive of the CE marking, and whether your product falls within this scope. Well, this is easier said than done: each directive generally contemplates different cases, exceptions, and exceptions of the exceptions...
You must also be careful to verify that the directive you are reading is the one currently in force, by checking the so-called "consolidated version" of the directive from the official website.
In short, if you have never carried out an Identification of the Applicable Legislation for the CE marking, at least for the first few times it is better to rely on an expert consultant in the subject, not only to save the time that would be necessary to familiarize yourself with the regulatory apparatus, but also to avoid the risk of running into errors of interpretation on the part of the manufacturer, which, unfortunately, are much more frequent than one might imagine.
Identification of the Applicable Legislation
If this premise has not yet discouraged you, you will find below a simplified (or an "oversimplified") scheme, to be considered as a "theoretical starting point" to understand how an Identification of the Applicable Legislation can be carried out:
- Check the official website (https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en) for the directives that can be definitely excluded. For example, the Low Voltage Directive will certainly not apply to products that have no electric parts.
- DO NOT exclude any of the directives from the start. For example, before excluding a device from the Low Voltage Directive because it operates in “Extra low voltage”, it is necessary to check the directive for the definition of the term “Low voltage”, which could be different from the meaning that is familiar to the manufacturer or the designer. To exclude the applicability of a directive, it is therefore necessary to read the directive to check if the product falls within the scope of application indicated, after having carefully read the definitions in the directive itself.
- Be aware of exceptions and "exceptions of exceptions". Sometimes it is enough to exchange a conjunction "and" with a conjunction "or" or with a double conjunction "and / or" to misinterpret a directive. Read it several times, and if you are not sure you have understood correctly, reconsider the possibility (if you have not already considered it) of contacting a CE marking expert.
At this point, you may have found several possibilities for your product:
- There is no CE marking directive applicable to the product: however, the General Product Safety Directive must be applied; you might think that this is the best-case scenario, but this is not necessarily true… Actually, in this case, lacking specific requirements means that it is up to the manufacturer to understand which particular requirement to apply, which is not always easy.
- Only one CE marking directive is applicable to the product: in this case, therefore, it will be enough to follow the directive in question. Also in this case you might think you are in luck, but that is not necessarily the case; the interpretation and application of the directive in question could, in some cases, be more complex than the application of several directives at the same time. Furthermore, considering that generally many products must be subjected to several CE marking regulations at the same time, it would be good to retrace the steps of the Identification of the Applicable Legislation in order to be sure that you did not exclude directives that had been mistakenly deemed not applicable.
- Several CE marking directives are applicable at the same time: a common situation. Here also, the advice is to contact an expert, due to the many questions that arise, including how the EC Declaration of Conformity should be written in the case of several applicable directives and which type of conformity check to adopt (e.g. internal production control, involvement of a notified body, etc.).
In conclusion…
Now, if you have been meticulous and patient, and if you have identified one or more applicable directives, you will have answered "CE marking yes", otherwise, if you have verified that no directive is applicable, the answer will be "CE marking no".
Not to demoralize you, but this is only the beginning: in fact, even if you were able to accurately identify the applicable rules, applying these rules and applying them correctly is quite another issue...
So, if the manufacturer will still have to turn to a consultant at the end of the day, does it make sense for the manufacturer to try to answer the question: should a product be CE marked or not?
Generally, the first (and certainly the least risky) action should be to contact the expert and wait for an answer.
On the other hand, the manufacturer, being responsible for the manufacturing process and for all possible health and safety risks attributable to the product, must understand what the CE marking is, what it is for, how it is carried out and how it should be maintained and updated over time.
The ideal situation, therefore, is that the manufacturer, in addition to asking for advice on CE marking, requests specific training in this regard, so that the CE marking process started during the consulting continues its function of protecting health and safety throughout the production process.
Having established that, regardless of the CE marking obligation, advice is always useful. The question that the manufacturer should ask himself is "Training for CE Marking yes or Training for CE Marking no?"
The answer is up to you ...
Do you need help for CE Marking?
How we help manufacturers, distributors and importers:
We offer consulting on CE marking to manufacturers, distributors and importers. This also includes:
- identification of the obligations for your specific products
- technical support in preparing the necessary documentation
- consultancy for the identification and implementation of safety measures (e.g.: selection of safe materials and components, design changes for safety, addition of protections, photocells and interlocks, safety operating procedures, personal protection equipment, affixing written warnings and pictograms, etc.).
How we help customers:
In addition to indirectly helping consumers by offering advice to manufacturers to market safe products, we provide support to consumers by providing them with information about the meaning of the CE marking and useful advice on how to choose compliant and therefore safer products.