Are E-Cigarettes regulated as Medical Devices?

Electronic cigarettes work by heating up a liquid until vaporization is reached. This is essentially another way of putting nicotine into your body. How are electronic cigarettes being regulated under EU Law? Are these to be considered as tobacco products or something else?

When is compliance with Medical Devices legislation necessary?

Nicotine containing products are regulated by the Tobacco Products Directive 2014/40/EU and the Medicinal Products Directive 2001/83/EC. However, electronic cigarettes stating medical claims (such as products used for smoking cessation programs) are required to comply with the Medical Devices Directive 93/42/ECC as well.

CE Marking needed even for single components of e-cigarettes

Single components pertaining to e-cigarettes that are marketed separately from liquids and are reusable (such as batteries, containers, heating elements, etc.)  will also have to follow the legislation on medical devices whenever they are linked to smoking cessation claims. Accordingly, for these parts of the e-cigarettes, it will be necessary to comply with the Medical Devices Directive and CE marking process.

Obelis at Your Service

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.

Alessandro Polimeno

in News