Dear all
The definition of Medical Device uses the term "disease" - as in "diagnosis, prevention, monitoring, prediction, prognosis, treatment o ralleviation of disease". I understand that normally we refer to disease as given in dictionary "any harmful deviation from the normal structural or functional state of an organism, generally associated with certain signs and symptoms and differing in nature from physical injury".. This is clear and I do not have any confusion here.
However, I would like to know is there any definition of 'disease" given by any Regulation (particularly EU Regulation) in the context of Medical Device definition.
This question has arisen, because one the companies that has designed a "customised software application that depicts the medical condition of a patient and the treatment procedure - particularly sugical procedure - in a video form - to be used by clinician to explain the medical procedure to the patients, and this company claims that it is a medical device, since it "alliviates the anxiety or fear of a patient of the impending surgery" and considers "anxiety or fear as a disease"
From the dictionary definition quoted above, I do not think that anxiety will fall under the definition of disease, though it may be considered as 'emotional or psychological disease or disorder" .
Hence I will appreciate if anyone can guide me to the definition of "disease" as per the medical device definition
Thanks and Regards
Sriram
The definition of Medical Device uses the term "disease" - as in "diagnosis, prevention, monitoring, prediction, prognosis, treatment o ralleviation of disease". I understand that normally we refer to disease as given in dictionary "any harmful deviation from the normal structural or functional state of an organism, generally associated with certain signs and symptoms and differing in nature from physical injury".. This is clear and I do not have any confusion here.
However, I would like to know is there any definition of 'disease" given by any Regulation (particularly EU Regulation) in the context of Medical Device definition.
This question has arisen, because one the companies that has designed a "customised software application that depicts the medical condition of a patient and the treatment procedure - particularly sugical procedure - in a video form - to be used by clinician to explain the medical procedure to the patients, and this company claims that it is a medical device, since it "alliviates the anxiety or fear of a patient of the impending surgery" and considers "anxiety or fear as a disease"
From the dictionary definition quoted above, I do not think that anxiety will fall under the definition of disease, though it may be considered as 'emotional or psychological disease or disorder" .
Hence I will appreciate if anyone can guide me to the definition of "disease" as per the medical device definition
Thanks and Regards
Sriram