European Union

HALMED is Croatia’s competent authority for medicines and medical devices, responsible for market surveillance and vigilance under EU MDR.

The Danish Medicines Agency is the competent authority for medical devices in Denmark, responsible for market surveillance and device vigilance

SUKL is the Czech competent authority for medical devices, responsible for market surveillance, vigilance, and enforcement under the EU MDR

IGJ (Health and Youth Care Inspectorate) is the Dutch competent authority for medical device market surveillance and enforcement under EU

Fimea is the Finnish competent authority responsible for regulation of medical devices, market surveillance, and vigilance.

INFARMED is the Portuguese competent authority for medical devices and pharmaceuticals, responsible for market surveillance and vigilance under EU MDR.

FAMHP is the Belgian competent authority for medicines and health products, including medical device market surveillance, vigilance, and clinical investigations.

AGES MEA acts on behalf of the Austrian Federal Office for Safety in Health Care (BASG) as the competent authority

HPRA is Ireland’s regulatory authority for health products including medical devices. It is responsible for market surveillance, vigilance, and clinical

MPA (Läkemedelsverket) is the Swedish Medical Products Agency responsible for regulation and surveillance of medical devices in Sweden under EU