Electronic cigarettes are to be regulated as medical devices if they do not contain nicotine

Electronic cigarettes are generally used for two purposes: either to help with the treatment of nicotine dependence or to serve as a replacement. When used for treatment, such products can be seen either as medicinal products or as medical devices – but how can a manufacturer decide on the classification of their electronic cigarettes?

Nicotine-free electronic cigarettes are medical devices

The electronic cigarettes which do not contain nicotine or any other active substance are not considered as medicinal products. In this case the classification of the product would depend on whether it serves a medical purpose. If the manufacturer attributes the medical claim of treatment to nicotine addiction to such electronic cigarette, the device will be considered as medical device and consequently must be CE marked.

Is the Medical Device Directive applicable in other situations?

In addition to the electronic cigarettes which contain no nicotine, other types of electronic cigarettes are considered to be medical devices as well. The nature and design of each individual product has to be examined. If the electronic cigarette is separate from the cartage and can be reused and refilled, than it will need to be CE marked as a medical device under the Medical Device Directive. The part of the electronic cigarette which contains the battery is seen by Competent Authorities as Class IIa – active therapeutic medical device. The cartage is to be considered as a medicinal product.

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If you wish to know more about regulatory issues under EU Law, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will answer any questions you may have and will gladly assist you in the process in safeguarding your products’ compliance.

Efrosina Zhivkova

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