Due to the fast progress in many areas of life, new regulations have to be invented. Especially in the area of medicine, where the human health is the key factor, the products need to be accurately tested prior to entering the market.
More like a medicine or rather a machine?
In case of some appliances it is not so easy to fulfil all the rules. For example, combination product which consists of a mechanism and an active ingredient may be tricky to examine. It could be hard to determine which element plays the chief part in the whole product: the biological (chemical) one or the mechanical part. To assist in the final choice, a special algorithm was created. Thanks to that, the producer can find out which agency shall be contacted. Nowadays a wide range of appliances like that are being designed, so likely the odds are that something similar has been invented in the past.
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This can make the choice simpler and as a result, the review can be shortened.
The future path of medicine
Drug-releasing implants or special wound patches – combination products become a fact, not just a fantasy in modern times. They can improve the standard of life for many patients. But to realise it, detailed evaluation is necessary. In the end, the appliance must be absolutely safe. Like any implant or medicine which has unblocked touch with the body, safety is the crucial element here.
When a given device passes all the tests, it can help with some issues that were so far hardly curable. The pathway is definitely hard, but the effect is worth the struggle.