The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) 2017/45 of the European Parliament and the Council of 5 April 2017 on medical devices…
…Reprocessing and reusing single-use products, regulated in Article 17 of the regulation, can be done by physical or legal persons, as well as by hospitals. Manufacturers of reprocessed products may only distribute the products directly to hospitals, as they are prohibited from sale to the public. Hospitals must inform patients of the use of reprocessed products in their hospitals and can use them exclusively on one patient and during one specific procedure…
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