Regulation (EU) 2017/745 establishes a European regulatory framework for health devices designed to ensure a high level of health safety and protection through stricter standards of quality, clinical evaluation and post-marketing surveillance. This regulation, which replaces previous directives, strengthens the responsibility of manufacturers and economic operators and introduces transparency mechanisms such as the single identification system (UDI) and the centralised EUDAMED database.
In addition, the regulation regulates conformity assessment according to the level of risk of each product and lays down stricter requirements for Class III and those that may be imposed. It also empowers health centres to manufacture and use products internally under specific conditions where the clinical needs of patients cannot be adequately met by market opportunities.