Dear all,
I have a short question regarding potential legal restrictions in the EU about distribution of medical devices to patients (end-user)...
(In my case - the medical device is a surface neurostimulation device.)
Is a legal manufacturer or its distribution site allowed (considering EU law and national law) to sell a medical device directly to patients?
Or is it necessary to sell first to a hospital or a similar medical facility (e.g. a medical supply store) and then only the medical facility is allowed to sell the device to a patient?
The questions is derived from some guesses regarding privat data protection... e.g. medical impairment of patients
Thank you very much for your support!
BR Aphel
I have a short question regarding potential legal restrictions in the EU about distribution of medical devices to patients (end-user)...
(In my case - the medical device is a surface neurostimulation device.)
Is a legal manufacturer or its distribution site allowed (considering EU law and national law) to sell a medical device directly to patients?
Or is it necessary to sell first to a hospital or a similar medical facility (e.g. a medical supply store) and then only the medical facility is allowed to sell the device to a patient?
The questions is derived from some guesses regarding privat data protection... e.g. medical impairment of patients
Thank you very much for your support!
BR Aphel