Complex Biomedical devices 2

As sue has mentioned in the comments of the previous post, at the first glance, cool.click™may seem a combination product, however it has to be categorized in one group to get through the legislations.

Normally, a device that is just used to DELIVER a drug ( as a syringe) is considered as a pharmaceutical product and should get through pharmaceutical legislations. However, sometimes this is the company who decides what is a main function of the product and how it wants to introduce its product and then gets through negotiations with legislative organisations to reach to an agreement about the nature of the product.

Does the device do something more than the drug delivery? Do mechanical parts or electronical parts have physical roles in the treatment,etc? These questions arise while deciding the category of the product. an example may be a coated stent.

In conclusion , It should be considered that the answer to these questions are not always very clear. Sometimes a product may be accepted as a medical device in Europe while as a pharmaceutical product in US and vice versa. The descision is made after discussions between companies and EMEA in Europe or FDA in the US.