CE marking of aesthetic equipment
THERE ARE MANY DIFFERENT PRODUCTS USED IN THE AESTHETIC FIELD. SOME ARE MECHANICAL INSTRUMENTS LIKE ROLLERS OR BALLS FOR MASSAGES MADE IN STONE OR WOOD, OTHERS ARE ELECTRICAL DEVICES.
IF YOU WANT TO PLACE YOUR AESTHETIC EQUIPMENT ON THE EUROPEAN MARKET, YOU HAVE TO KNOW THAT THE LAW REQUIRES THE TECHNICAL FILE FOR EVERY PRODUCT, WITHOUT ANY EXCEPTION.
IN-DEPTH
WHAT’S THE EUROPEAN LAW FOR AESTHETIC EQUIPMENT?
Legislative decree of 2015, n. 206 of 10 October identifies all the aesthetic equipment that can be used in beauty salons. This decree contains various technical sheets that clarify the families, the types and the technical characteristics that aesthetic products must comply with in order to be used in beauty salons.
In any case, the technical file is mandatory for all products put into free circulation within the European Community.
If your product needs the CE marking and you are the manufacturer, you need an authorised representative in Europe to make it.
THE ESSENTIAL HEALTH AND SAFETY REQUIREMENTS SHOULD BE
SATISFIED IN ORDER TO ENSURE THAT THE PRODUCT IS SAFE
LAW REQUIRES THE TECHNICAL FILE FOR ALL PRODUCTS, WITHOUT ANY EXCEPTION
THE LAW PUNISHES THOSE WHO PLACE PRODUCTS ON THE MARKET WITHOUT PROVING THEIR NON-DANGEROUSNESS IN A FORMAL WAY
ONLY A RESIDENT IN THE EUROPEAN COMMUNITY CAN CARRY OUT THE CE MARKING
Aesthetics or aesthetic medicine?
It often happens that the borderline between aesthetics and aesthetic medicine is very thin and the legislative decree of 2015, n.206 of 10 October indicates the limits for machines destined to the aesthetic activity, which have never to cross in the therapeutic treatment cause it’s proper of the medical field and must be performed by doctors only.
Aesthetic equipment has to be used by qualified personnel, unless it has been designed and built for domestic use, which is governed by even more binding regulations concerning safety. In the latter case, they do not need any certificate, but must comply with specific rules and especially the limits indicated by the ministerial files.
In any case, the technical file is the fundamental documentation that constitutes the formal part of the CE marking, it must always be stored in the company and must be made available to the market control authorities.
Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the product with the essential health and safety requirements.
THE CE MARK
BASE INFOS
Do you know the basic information on CE marking?
What’s the CE marking?
The CE marking is a mandatory procedure for all products covered by a Community directive, it must be carried out by the manufacturer or the authorised representative established in the European Union, which declares by means of the Declaration of Conformity (or Performance for construction products only), which the product complies with the safety and health requirements, provided for in the relevant Community directives or regulations in addition to avoid problems with the authorities and the police in case of control.
Who should make the CE marking?
The CE marking is a process that must be carried out by the product manufacturer or his authorised representative established in the European Community who, with the Declaration of Conformity, declares that the product complies with the safety and health requirements of the law. You can ask for advice on CE marking, but you can’t let others do it, unless you name a representative, that is, a legal agent. In any case, anyone who sells the product under his own name is totally responsible for it.
If you live in a non-EU country, can you mark CE your product?
No, the directives clearly clarify that ONLY a resident in the European Community can carry out this activity.
Therefore, if a non-European subject supplies a CE marked product, that mark is always illegal, even if the product complies with European laws. It is necessary to distinguish between the product, which enters the EU market, and the producer, if it is outside the EU, the law demands a substitute (importer or agent).
Beware of scams! What is the CE certificate?
The certificate or certification is NOT the CE mark, on this aspect there is a lot of confusion and many scams, for customers and for the authorities. At most, a certificate is a component of the CE mark but does not replace it. Never!
On the CE marking many have an interest in creating confusion! We help you to clarify and you can have our assistance and advice.
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