European Union

AEMPS is the Spanish competent authority responsible for ensuring the quality, safety, and efficacy of health products including medical devices, […]

AIFA works alongside the Italian Ministry of Health for medical device regulation in Italy. The Italian Ministry of Health’s Directorate

BfArM is the German federal institute responsible for medical device regulation, market surveillance, and vigilance. It manages the German medical

The European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) coordinates EU medical device regulation. EUDAMED is

ANSM is the French competent authority for health products including medical devices. It is responsible for market surveillance, vigilance reporting,