EN 60601 Medical Electrical Equipment and Systems

Gain market access in Europe with EN 60601 and CE marking

EN 60601 Medical Electrical Equipment medical devices BSIManufacturers who wish to place Medical Electrical Equipment on the European market must apply CE marking to their device to indicate compliance with applicable European Medical Device Directives.

The Medical Device Directives contain Essential Requirements that must be in compliance with harmonized standards as this is the preferred way of demonstrating this since they offer a 'Presumption of Conformity'. This makes understanding and meeting the requirements of EN 60601 fundamental for all manufacturers of Medical Electrical Equipment.