Similar device

Similar devices give context in clinical evaluation, for example to describe the state of the art and to identify hazards. They are not equivalent devices, whose data can be claimed only after equivalence is shown under strict criteria.

• ‘similar device’: devices belonging to the same generic device group. The MDR defines this as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2

Devices belonging to the same generic device group (per MDR Article 2(7)). The MDR defines this as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics (per MDCG 2020-6)

MDCG 2024-10, Section 1, Abbreviations and terminology