Real Decreto n° 414/96 de 01/03/1996, por el que se regula los productos sanitarios BOE n° 99 de 24/04/1996 Página 14670 (Marginal 9089)

This Royal Decree from Spain establishes the regulations for medical devices. It aims to ensure the safety and performance of these products available on the market. This regulation affects manufacturers, importers, and distributors of medical devices within Spain, setting standards for their placing on the market and putting into service.