EN 60601 and conformity assessments

Manufacturers who wish to place medical electrical equipment onto the European market must apply CE marking to their device to indicate compliance with the Medical Device Regulations.

Compliance with the state-of-the-art standards is the preferred method of demonstrating conformity with the applicable General Safety and Performance Requirements (GSPR) of the Medical Devices Regulation (MDR) (EU) 2017/745.

Whilst compliance with the standards is not mandatory for CE marking medical electrical equipment under the MDR, it can be the most efficient conformity assessment route to achieve CE marking.

There are currently no standards harmonized to the Regulations; however, for manufacturers of medical electrical equipment that is CE marked under the Directives, understanding and meeting the requirements of EN 60601 is essential as this is a state-of-the-art standard, which can therefore be applied to show conformity with the GSPR of the Regulation.

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