Vaporiser and other medical devices for Medicinal Cannabis, the CE-marked Device (10485)

Vaporisers are on the rise. Learn here all about the tasks to successfully CE-mark your vaporizer for medicinal cannabis and how to fulfill requirements for other medical devices, e.g. for dosing and packaging e.g. syringes.

Medicinal cannabis (flowers or extracts) is often delivered or administered to patients by vaporisation. In the EU, vaporisers used must be classified as medical devices and require a respective CE mark. The distribution or promotion of non-certified vaporisers in the context of medicinal cannabis is illegal.

The general safety and performance requirements for EU CE marking are defined in Annex I of the Medical Device Regulation (EU) 2017/745 (MDR). For these products, a conformity assessment procedure is to be carried out and a certification body (Notified Body) is to be involved. This applies to all vaporisers but might be different for other medical devices, depending on the potential risk of the device. For this purpose, the MDR provides for a differentiation of the devices into 4 main classes (I, IIa, IIb, III). This classification is based on the criteria laid down in Annex VIII of the MDR. Vaporisers of medicinal products are categorised as IIb (rule 20 of Annex VIII of MDR and related explanation in MDCG 2021-24 "Guidance on classification of medical devices"). Thus, the conformity assessment must essentially be carried out with the involvement of an EU Notified Body. Furthermore, risk class IIb requires clinical investigations carried out with these medical devices. Notified Bodies perform the conformity assessment, the potential tests and issue the corresponding certificates. Manufacturers can contact a European Notified Body of their choice, which is designated for the relevant procedure and the relevant product category.

Conformity assessment is the process demonstrating whether the requirements of the MDR relating to a device have been met. The responsibility for demonstrating conformity lies with the manufacturer of the medical device. Data obtained will then be assessed by a Notified Body. In any case the general safety and performance requirements, the clinical performance and the technical documentation will be assessed by the Notified Body. The devices must also be assigned a Unique Device Identifier (UDI) number and be registered in the electronic system EUDAMED, in accordance with MDR Article 29.

This webinar will address the following topics:

• Why are vaporisers regulated as medical devices?
• What is a CE mark and how to obtain it?
• Which general safety and performance requirements, clinical performance and the technical documentation are to be established for a given vaporiser intended for CE marking?
• Which obligations apply to manufacturers after CE marking for a vaporiser used as a medical device?
• What is to be understood about the EC Certificate of Conformity?
• What are possible ways to market a vaporiser with the medicinal cannabis product?
• Can any CEmarked product be placed on the EU market?
• What are the economic operators involved in placing a CE marked product on the EU market?

Duration (Recording): 130 Minutes
Language of presentation: English | Slides: English

...more from your speaker Fabio Cirillo

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