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Statement on Medical devices

Celtic Magic products are not designed for the above, however, they are designed to allow access to everyday technologies such as PC computers and other common digital devices such as tablets, phones and call systems.  

When a Celtic Magic product is in development, where necessary, we will consult with the MHRA* which is the body responsible for regulating Medical Devices.   We have been advised by the MHRA* that in their formal opinion, our products are not Medical Devices but are classed as "Aids for Daily Living". 

It would be improper of Celtic Magic to class a product as a Medical Device when the regulatory body advises that it is not.
 

On occasions, some other organisations such as health care institutions or insurance companies will require that devices must be Medical Devices as their own internal policies demand such.  However such policies may be created arbitrarily and outside of the guidance from the actual body that administers Medical Devices.   

Such positions should be reviewed on a case-by-case basis if the user in need requires technology as an Aid for their Daily Living, such as to type an email, turn on a TV, control their environment, or activate a call for assistance.   Conversely, it would be inappropriate to use a non-medical device to self-administer pain control medication.

Celtic Magic

2023

* Medicines & Healthcare products Regulatory Agency

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What is a "Medical device" ?


An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.

 (World Health Organisation)

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