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Medical Device Distribution in the EU to Patients (End-Users)

Aphel

Involved In Discussions
#1
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
 
Elsmar Forum Sponsor
#2
Re: Medical Device Distribution

A manufacturer may sell directly.

There is no classification, in the EU, of devices as being "OTC" or "Prescription Only"

If a manufacturer is selling products for a particular purpose, for example treatment of incontinence, they are in effect collecting confidential and potentially embarrassing medical data of their customers. I would expect and hope that such data would be treated in the same way as a clinical institution. (Strict staff confidentiality, secure data storage etc).

I believe there are standards and legal requirements for such data collection / storage but that is not something I have much knowledge on, but the "Medical Information Technology, Medical Software and Health Informatics" sub-forum may be able to help.
 

pkost

Trusted Information Resource
#4
The Data protection act 1998 is only relevent and enforacable in the UK

There is a data protection directive that encompasses the EU, however the transpositions of this directive (including the UK act mentioned above) vary considerably between member states - even more so than the MDD!
 
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