This article shows how the EU Medical Device Regulation (MDR) can open a route into the EU market for certain e-cigarette products, and explains how split-type devices can stay outside the Tobacco Products Directive and the Medicinal Products Directive – a different market-access path for e-cigarette companies.
As the e-cigarette market keeps growing, more and more manufacturers want to place their products on the EU market legally. The EU framework is strict, however: the Tobacco Products Directive (TPD, 2014/40/EU) sets tight limits on e-cigarettes. Is there a way for an e-cigarette to enter the EU outside the TPD?
Yes – via the Medical Device Regulation (EU) 2017/745 (MDR). In certain cases an e-cigarette can be regulated as a medical device rather than under the TPD.
Below we explain how e-cigarettes can be placed on the EU market as medical devices under the MDR, and how different product types can meet the EU’s strict requirements.
1. How can an e-cigarette enter the EU under the MDR?
Under the MDR, some e-cigarette products can be regarded as medical devices – in particular where a medical purpose is claimed, such as helping users quit smoking or treating nicotine dependence. Such products are no longer ordinary consumer goods and are regulated as medical devices.
How to comply with the MDR
- Medical purpose claim: If the product is claimed to help users stop smoking or relieve withdrawal symptoms, it must go through the MDR route. It needs CE marking under the MDR and must meet the MDR requirements for safety, performance and the quality management system.
- Clinical data: For a medical use, the manufacturer must provide clinical data supporting efficacy and safety in order to obtain certification.
- Design and testing: As a medical device, the product must undergo appropriate performance testing to demonstrate its effectiveness in treating nicotine dependence or supporting smoking cessation.
2. Disposable e-cigarettes: the Medicinal Products Directive may also apply
If the product is single-use and explicitly claimed to treat nicotine dependence or support smoking cessation, it may have to comply not only with the MDR but also with Directive 2001/83/EC on medicinal products (MPD). The MPD applies to products with a clear therapeutic or preventive action.
When the MPD applies
- Therapeutic claims: If the marketing refers to treating smoking or relieving nicotine withdrawal, the manufacturer must provide clinical trial data proving efficacy and obtain a marketing authorisation for a medicinal product.
- Pharmacological action: If the product relies on the pharmacological action of nicotine to relieve withdrawal symptoms, it is classified as a medicinal product and must meet the MPD requirements.
Particular challenges for disposable products
- Clinical trials and marketing authorisation: As a medicinal product, a disposable e-cigarette may need more extensive clinical data and trials and a marketing authorisation procedure, which is more complex and time-consuming than MDR certification.
- Market access: Once the MPD requirements are met, the product can be placed on the market as a medicinal product, but the process involves more regulatory review.
3. Split-type e-cigarettes: the device body can be MDR-certified on its own
If the e-cigarette is a split design – the device body and the cartridge are separate and the cartridge is only a test accessory – the device body can be certified under the MDR on its own, without also having to meet the MPD and the TPD.
Advantages of a split design
- Certification of the device body: If the device body mainly provides the nebulising function, it can be certified as a medical device under the MDR. It then does not need medicinal-product clinical data and is not subject to the MPD.
- Outside the TPD: The device body contains no active substance, so it can be certified under the MDR without being subject to the TPD restrictions such as tank-volume limits and nicotine-content requirements – a more flexible market-access route.
How certification works
- Design and performance: As a medical device, the device body must meet the MDR requirements for safety, performance and quality management, obtain CE marking under the MDR and demonstrate its effectiveness for the intended medical use.
- Cartridge as an accessory: If the cartridge is only a test accessory and carries no medical claim, it does not need MDR certification but must comply with the TPD or the MPD as applicable.
4. A new approach in an increasingly regulated EU market
EU regulation of e-cigarettes is becoming ever stricter. CE marking under the MDR offers a special route that lies outside the TPD and the MPD. It can help manufacturers avoid some of the strict tobacco-product restrictions while ensuring legal compliance for medical use – especially for products that claim to support smoking cessation.
5. How EVERBIZ can help
A small number of EU notified bodies currently accept MDR applications for e-cigarette products. EVERBIZ has extensive MDR experience and supports e-cigarette companies end to end – from the MDR application strategy and preparation of documentation and clinical data to communication with the notified body.
For more details on MDR certification of e-cigarettes, or to request our guidance white paper, please use the download link below or contact us.
Download: E-Cigarettes under the EU MDR – Download