Because of the quick development in many fields of life, new regulations need to be created. Notably in the field of healthcare, where the human well-being is the key factor, the products ought to be thoroughly tested before they enter the market
More like a drug or rather a machine?
In case of some appliances it is quite challenging to fulfil all the regulations. For instance, combination product which consists of a mechanism and a drug may be tricky to examine. It could be challenging to determine which component plays the chief role in the resulting product: the medical (chemical) one or the device element. To assist in the decision, a dedicated algorithm was devised. Thanks to that, the producer can determine which agency
should he contact . Nowadays a wide range of appliances like that are being designed, so there is a big chance that something comparable has been invented beforehand. This may make the choice easier and as a result, the assessment can be shortened.
The future development of medicine
Drug-releasing implants or special wound patches – combination products become a fact, not just a fantasy any more. They can improve the standard of living for many chronically diseased people. But in order to achieve it, strict evaluation is needed. After all, the product has to be sufficiently safe. Like any implant or drug that has unblocked touch with the body, safety is the critical factor here.