CBD based products registration in EU and UK

Elsmar Forum Sponsor

Raisin picker

Quite Involved in Discussions
#2
MDR, Article 1 (1):
medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
If you can find an intended use where the CDB does not act pharmacological, then yes. Good luck there ;-)
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#3
CBD is just becoming regulated in the USA. I am not sure it will qualify for a medical device.
 

Vetty007

Starting to get Involved
#5
Exciting question, basically I would say that this is possible, but you will easily end up in class III due to the pharmacological effect and as already said. Authorities are very crazy with CBD products (in general they try to ban them) and even hemp products and I had a lot of discussions with them about simple hemp oil saying that it contains Cannabinoids (CBD is not even mentioned). However, I couldn't think of any typical medical device that would make sense to be prepared with CBD having only an additional effect - I can't really imagine that e.g. wrist bandages that possibly releases CBD or something like that would be effectively enough. But possibly I am just not creative enought.
 
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