The purpose of this information is to clarify the legal status of the BeautyTeck device.
The European law defines the scope of a device class by its intended uses. Only devices which have a medical intended use can be considered medical under the current Medical Devices Directive (MDD), this is clearly stated by the current European Legislation and this is a view adopted throughout all the member states. However this will change in 2020, despite that plasma devices will be unlikely to be regulated by the new MDD .
The BeautyTeck device has only aesthetic intended uses. This means that a declaration of conformity (drawn by the legal manufacturer) suffices to affix a valid CE mark. The CE mark is recognized not only in Europe but also in several non EU countries including South Africa (see South Africa trading agreement and more here). In all the countries where a valid European CE mark is accepted by the competent authorities our CE mark is also valid. In any country in which CE Mark devices are accepted also the same intended uses rule is accepted. If a country competent authority accepts a medical CE mark (unless otherwise expressed by the local legislation) also a valid CE mark for aesthetic uses shall be acceptable also.
The Beautyteck is a non medical device is also confirmed by the UK Authorities.
The intended uses of the BeautyTeck have been carefully selected to make sure that they did not fall under the remit of the Medical Devices Directive (MDD). In 2015 several enquiries have been made in writing to the competent authorities (the MHRA and the HSE) who both confirmed in writing that the intended uses were indeed non medical but aesthetic. Therefore it was established in writing that the authorities themselves consider the BeautyTeck’s intended uses as non medical but aesthetic. Therefore the Beautyteck is not classed as a medical device but as an aesthetic device. The same device classification shall be accepted in all other countries who who allow the commercialization CE Marked devices in their territory.
What happens to the CE mark when a device is not medical?
When the device is not medical a simple declaration of conformity drawn by the manufacturer is accepted and valid. If the manufacturer is based in Europe the manufacturer is also legally identified as the “responsible person”. The declaration of conformity is sufficient to affix a valid CE mark and place the device on the market. Therefore there is no need for any pre-authorization or documents issued by any authorities in order to affix a legally valid CE mark and place the device on the market.
Should any concern regarding the conformity of the device to European Standards be raised, the competent authority in their country can request the manufacturer or “responsible person” to submit the technical file for inspection. After the request made by the competent authority, the “responsible person” or manufacturer has 14 days in order to submit the technical file to the competent authority. Upon examination the competent authority can then file motion to prosecute the manufacturer or responsible person, this is expensive and unlikely to be successful in the courts, provided that the manufacturer has carried out all the relevant due diligence.
In the case of the BeautyTeck, given the market disruption caused by the innovation brought by this product, the technical file and related documentation supporting the CE mark was voluntarily submitted to the competent authority (the Health and Safety Executive) before any request was made and before the device was placed in the market. This provided the competent authority the opportunity to raise any concern before the device was placed on the market. After some questions made by the competent authority, the HSE did not make any objections and the device was placed in the market. Copy of all this correspondence is kept on file.
Here are the links to some of this correspondence:
What happens to the certificate of free sale in case a device is non medical?
In case of medical devices the certificate of free sale is issued by MHRA. In case of any other product where a self declaration of conformity is sufficient, the certificate of free sale (for any country which requires it) is issued by the manufacturer themselves (or the responsible person) . In case of the BeautyTeck this is the certificate of Free Sale.
What if the BeautyTeck is considered as a Medical device in my country?
It is possible that Voltaic Arcing Devices for aesthetic uses are considered medical instruments in certain countries which do not recognize the validity of the CE mark in their territory. In this case this device is required to undergo certain bureaucratic procedures before being placed in the market.
However this device can be used legally for the same aesthetic uses as in Europe in any country which recognizes CE Marks. Please note that if CE Marks are recognized in a territory there is no argument to state that in that a CE mark for an aestheitc uses alone is not valid and only the medical CE is Valid. If fact if a Medical CE is valid also the aesthetic CE is valid and the same interpretation as in the EU is assumed unless expressedly stated by the local legislation.