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New combination products and their legal permission procedure – what to get ready for?

Lots of the most ingenious medical solutions are in reality combos between drugs and devices that in general involve a piece of medical tool and a part of medicine.


device contract
Author: Centrum Naturhouse
Source: Centrum Naturhouse




Combined solutions are often medical tools covered or impregnated with a medication substance, such as a catheter with an antimicrobial coating or a pharmaceutical covered stent. Other examples of ingenious solutions include bone-containing cements incorporating antibiotics and spermicide-coated contraceptives.


Regardless of the medical advantages allowed by combined instruments in the cure of various medical cases, the process of regulatory cross-examination and permission for combination products is frequently more complicated than that applied to unbound products. For example, in the European Union, the evaluation on medical inventions incorporating medicines should involve the opinion of an adequate authority designated by the EU member country. Innovative product producers are encouraged to estaplish a detailed regulatory strategy, as soon as possible, in the procedure of creating new combination products. An effective regulatory project contains a complex plan to go through the invention approval process, coherent with the device contract and the manufacturer's plans for its market launch. Manufacturers of combined products should also demand the judgement of the competent authorities and autonomous third parties as concerns the documents to be provided in backing of the CE marking norms.


These stages are adopted to make the authorization procedure as efficient as possible and can help reduce the risk of sudden and contractual delays that could extend or unable device permission.