Medical Devices Electronic Cigarettes

Medical Devices Electronic Cigarettes

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Medical Devices Electronic Cigarettes
Medical Devices Electronic Cigarettes
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The regulation of nicotine-containing products (NCP)

There is a great interest in the regulation of nicotine-containing products (NCP), either to help smokers break their dependence to nicotine that comes from tobacco products or simply as a replacement.

A relatively recent newcomer is the eCigarette.

Two directives apply in the regulation of Nicotine Containing Products:

Only one directive can be applied for any particular product and the appropriate directive will be determined by the manufacturer’s claims and specifications.

Tobacco Products Directive

The Tobacco Products Directive (TPD) applies if the eCigarette manufacturer doesn’t make medical claims and the following criteria are satisfied:

  • Maximum cartridge / tank size 2 ml
  • Maximum refill container volume 10 ml
  • Maximum concentration 20 mg/ml nicotine

In this case, the European Member States are required to apply the measures set out in the TPD from 20 May 2016. The Member State’s nominated Competent Authority will be responsible for regulation and oversight. There is no requirement for Notified body involvement with eCigarettes regulated under the TPD. To read further advise please visit the MHRA website - E-cigarettes: regulations for consumer products.

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

A notified body’s perspective on the clinical evaluation requirements under the Medical Device RegulationUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article >

Medicinal Product Directive

Addiction to a chemical substance is a medical condition and any product which claims to treat an addiction with supportive clinical data falls under the Medicinal Product Directive (MPD).

eCigarettes which do not meet the criteria set above for the TPD are regulated under the MPD. The manufacturer must obtain a marketing authorisation for medicinal products for human use for the nicotine-containing product (NCP) - see Legal Framework. The Notified Body has no involvement in the approval of the marketing authorization for medicinal product. However, as an electronic cigarette contains components such as a battery and heating element, legislation relating to medical devices is also relevant. Since, in many cases, the delivery / administration part of the electronic cigarette supplied separately from the nicotine-containing product will be regarded as a medical device, it will require to be CE marked under the medical device regulations.

Applications for the NCP (medicinal product) and the delivery system supplied separately to NCP (device) may run in parallel. A CE certificate can be issued once all Notified Body and Medicines Agency conformity assessments have been successfully completed.

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