Ingenious combination products and their legal permission process – what to get prepared for?

Lots of the most ingenious medical solutions are actually combinations between drugs and devices that usually include a part of medical tool and a component of medicine.

device contract

Autor: Centrum Naturhouse
Źródło: Centrum Naturhouse
Combined inventions are commonly medical tools covered or impregnated with a medication substance, for example a catheter with an antimicrobial layer or a pharmaceutical coated stent. Other cases of ingenious products include bone-containing cements consisting of antibiotics and spermicide-coated condoms.
Despite the clinical profits offered by combined devices in the treatment of some medical conditions, the procedure of administrative cross-examination and authorization for combination products is usually more complicated than that applied to unbound products. For example, in the European Union, the evaluation on medical products incorporating medications should include the judgement of a competent authority nominated by the EU member state. Combination product manufacturers are encouraged to estaplish a precise regulatory strategy, as soon as possible, in the procedure of developing new combination products. An efficient regulatory project determines a comprehensive plan to pass through the device approval process, consistent with the device contract and the producer’s ideas for its market inauguration. Inventors of combined products should also solicit the opinion of the adequate authorities and autonomous third parties as concerns the documentation to be presented in backing of the CE marking norms.

These steps are adopted to make the authorization procedure as productive as possible and can help reduce the risk of unforeseen and contractual delays that could prolong or unable solution approval.
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