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Ingenious combination products and their legal authorization process – what to be ready for?

Lots of the most inventive medical instruments are actually combinations between pharmaceuticals and devices that usually include a piece of medical tool and a component of pharmaceutical.

device contract
Author: Centrum Naturhouse
Source: Centrum Naturhouse

Combined products are commonly medical instruments covered or impregnated with a medication substance, such as a catheter with an antimicrobial layer or a drug covered stent. Other illustrations of inventive products include bone-containing cements consisting of antibiotics and spermicide-covered condoms.

Regardless of the clinical advantages offered by combined instruments in the treatment of certain medical cases, the procedure of administrative audit and authorization for combination products is in general more complicated than that used for unbound solutions.

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For example, in the EU, the evaluation on medical products incorporating pharmaceuticals should include the judgement of an adequate authority designated by the European Union member country. Combination product producers are encouraged to estaplish a detailed regulatory project, as fast as possible, in the process of developing new combination products. An effective regulatory project specifies a detailed plan to go through the device permission procedure, coherent with the device contract and the producer's plans for its market launch.

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Manufacturers of combined solutions should also request the opinion of the adequate authorities and independent third parties as concerns the documentation to be presented in backing of the CE marking requirements.

These stages are used to make the approval procedure as efficient as possible and can help reduce the risk of unexpected and contractual delays that could protract or compromise device approval.