The problems connected with combination products evaluation: how to make the modern solution available for patients?

Because of the fast progress in many areas of life, new laws need to be created. Notably in the field of healthcare, where the people’s well-being is the key factor, the products need to be accurately tested prior to entering the market.


Autor: pang yu liu
More like a drug or rather a device?

In case of a given range of appliances it is not so easy to proceed with all the rules. For example, combination product that consists of a mechanism and a drug might prove tricky to examine. It could be challenging to determine which element plays the main role in the resulting product: the medical (the drug) one or the mechanical part. To assist in the decision, a dedicated procedure was designed. Thanks to that, the manufacturer can recognize which agency should he contact . Nowadays a multITude of appliances like the described are being designed, so likely the odds are that something similar has been invented beforehand. This might make the choice simpler and as a result, the assessment can be faster.
The future development of medicine
Drug-eluting implants or special wound plasters – combination products are becoming a fact, not just a fiction in modern times. They can improve the comfort of living for many of potential recipients. But in order to realise it, detailed evaluation is necessary. After all, the appliance must be absolutely safe. Like any implant or medicine that has a direct touch with the body, safety is the crucial factor here.

When a given product passes all the examinations, it could help with some diseases that were so far hardly curable. The road is definitely full of obstacles, but the effect is worth the struggle.