This resource discusses the regulatory requirements for e-cigarette products under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), and is a reference for manufacturers of e-cigarettes or related vaping products making medical claims such as smoking cessation or harm reduction.
About this document
Ordinary consumer e-cigarettes in the EU are mainly governed by the Tobacco Products Directive (TPD). However, if a product claims a medical purpose such as aiding smoking cessation, it may qualify as a medical device and must be classified, undergo conformity assessment and bear the CE marking under the MDR. This resource outlines how such products are qualified under the MDR and the main compliance requirements.
Applicable products and users
- E-cigarettes and vaping devices claiming medical purposes such as smoking cessation or harm reduction
- Companies planning to enter the EU market with such products as medical devices
Main contents
- When an e-cigarette qualifies as a medical device
- Classification and conformity assessment routes under the MDR
- Technical documentation, clinical evaluation and labelling requirements
Download
Related articles
- MDR (Regulation (EU) 2017/745) Amending Acts
- The Interplay Between the MDR/IVDR and the AI Act (AIA)
- The EU Plans to Significantly “Lighten” the MDR: What Will Change for Certificates, Clinical Evidence and Notified Body Audits?
- EU Medical Device CE Certification (MDR/IVDR) Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.