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Decoding The First-Ever MDCG Guidelines For Annex XVI Produc

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The newly proposed MDCG guidelines are a valuable resource for manufacturers (of products without an intended medical purpose), notified bodies, and stakeholders navigating the intricate landscape of medical device regulatory standards. A comprehensive review of these guidelines is crucial to maintain the safety and efficacy of medical devices in the market. In conclusion, when embracing these guidelines, it is crucial to understand the guiding principles and consider the similarities with medical devices.
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