Selling with a Medical Device App

[Ben S UK]

Hi,

Are the any regulations or rulings people are aware of related to whether you can, or cannot, advertise or even sell (via d2c) within a medical device app within the EU.

For example if you developed an app which supported diagnosis of condition x, would it be acceptable to within the same app to sell products designed to treat condition x?

 

[mihzago]

You'll have to get an explicit consent from each user/patient, especially in EU. I would be extremely careful if you're promoting third-party products.
Either way you should consult this with a privacy lawyer.

From a customer perspective, be careful how often and what you promote. As a user/patient, I would not be happy if I'm frequently getting ads to buy stuff when I use the app.

There may be other legal or regulatory considerations.

 

[Ben S UK]

Hi Mihzafo,

thanks for the response.

Absolutely agree on the watch outs from a consumer/patient pov in terms of position.

I think what I am trying to understand is does the MDD/MDR or any case law/guidance prohibit the use of an mhealth app to facilitate ecommerce in addition to the apps primary intended purpose.

So, hypothetically speaking, if you developed an app to help users diagnose eczema, as a IIa medical device standalone software. Then in the app once the diagnosis was presented to the user "you have eczema" you then linked to a range of products you also manufactured that could be used in the treatment of eczema.

 

[Sarah Stec]

You may not find something that says "thou shalt not (or may) conduct e-commerce in your medical device app."

I think you may find things that talk about (and I would start here):
-The limits of clinical decision support software (a recent ECJ decision may be helpful here, and analyzing the MDR),
-The boundaries of the practice of medicine (at what point is your app doing the doctor's job of determining the best treatment for the patient and their condition),
-The privacy of the patient and their diagnosis (would you be able to track sales of your product through the app if the sale of the product is tied to a person's diagnosis?), and
-Liability issues (i.e. if you sell a product that the person ends up being allergic to, which a doctor would have advised against given the person's allergies...).
To add a layer of complexity, these things may be different from member state to member state too. You may want to examine whether and how your classification would change if you add the functionality to provide treatment options as well.

 

[dgrainger]

If the product your app promotes is a medicine then there is a lot of legislation you need to think of. For the UK look here:
Blue Guide: advertising and promoting medicines - GOV.UK

Under the MDR software classification rule 11 this new functionality is likely to up rate the classification.