European Communities (Medical Devices) (Amendment) Regulations, 2002 SI n° 576 du 11/12/2002

These regulations amend existing Irish laws concerning medical devices, ensuring they align with European Union standards. This aims to harmonize the market and improve patient safety across member states. Manufacturers and distributors of medical devices operating in Ireland will be most affected. The changes focus on updated requirements for device approval, safety monitoring, and market surveillance.