Is your product considered a medical device?

The answers to the following questions have all an impact on whether your product is considered a medical device from a legal perspective.

The overall assessment of the product’s categorisation will focus on how the product’s “Intended Use“ and “Claims” are formulated by the manufacturer. Please consider your words carefully and formulate the answers in the same way as if it were the final sales material you would phrase.


For a Danish version of the e-form: http://goo.gl/iYCJFv
Product type



Accessory
Is your product accessory for an existing product?

 
What is the purpose of your product (intended use)?
Describe the purpose of the product in five to ten lines. Describe the purpose in the same way as if you were to describe the product for an end-user or an investor. Emphasise what it does and how the user will benefit from the product. Explain in max. 5 lines how the product technically achieves these things (without going into too much detail).
Who is the user of the product?
What characterises the typical user of the product? Is it men, women, children, etc.? Do they have a particular illness, disability, condition etc.? Is the intended product user layman, doctors, nurse, etc.? (The answer may be divided into primary, secondary, tertiary uses.)
Distribution
In short: How do you plan to distribute the product? (e.g. over the counter, through a municipality, a hospital, the family doctor, etc.).
Marketing (claims)
Describe how the product is marketed? What are you going to claim that the product is able to do for the user (e.g. reduce blood clots, prevent readmissions, optimise workflows, prevent inflammation, etc.). Describe any process / method your product will replace or improve.
Other information (optional)
Is there any other information that might be relevant for us. For example: Is there a bigger vision with the product? - Does the product already have a website? - Is there access to a prototype? - Is the product already EMC approved? Etc.
I would like the report to be in:


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