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For instance, in the EU, the assessment on medical inventions including medications should involve the judgement of a competent authority elected by the European Union member state. Combination product inventors are encouraged to estaplish a precise regulatory plan, as fast as possible, in the process of developing new combination products. An efficient regulatory project provides a complex plan to go through the invention permission process, coherent with the device contract and the manufacturer’s plans for its market inauguration.
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Inventors of combined solutions should also request the opinion of the adequate authorities and autonomous third parties as concerns the documentation to be presented in support of the CE marking norms.