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Clinical tests | Other scientific references | What is a medical device?
SCIENTIFIC DATA
What is a medical device?
This official European statute concerns products with a medical function of which has an action essentially physical or mechanical which is different to a drug that has an action primarily pharmacological (European Directive 93/42/CEE of 14 June 1993).
Definition of a Medical Device:
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of, prevention, control treatment or alleviation of a disease" by an action primarily physical or mechanical.
Migrastick has a double action: massage + cold
Essential requirements
Medical devices must respond to the "essential health and safety requirements", they must not compromise the safety and health of patients and users.
Classification
  • 4 classes: I, IIa, IIb, III
  • device classes based on their criteria relative to the risk level
  • Utilisation duration, invasive in nature or not, animal origin...
Migrastick is a class I medical device, corresponding to the lowest risk level.
Evolution of Conformity
The presence of the mark CE on the product = guarantees the conformity and the safety recognised by all the European Union Member States.
Migrastick is officially recognised as being a class I medical device "to relieve the pain associated with headaches and migraines".
Migrastick has been registered as a medical device since July 2000 with the MDA (Medical Devices Agency) in England, under the European Directive  93/42/CEE 14 June 1993.
The massage effect
   and the cool sensation provided
by Migrastick
  relieves the pain
associated with
headaches and migraines
Groupe Arkopharma
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