Accessories for a medical device are items that are not medical devices themselves but have been designed to be used together with one or more medical devices. They either help to ensure that the medical device is used correctly or directly support its medical function in a targeted manner to fulfil the intended purpose of the device.
The term is defined for the legal area of the European Union by the MDR, Chapter 1, Article 2, Paragraph 2.
An example of an accessory for a medical device is a blood pressure cuff. It is not a medical device in its own right, but is used together with a blood pressure monitor. The cuff helps to use the blood pressure monitor correctly and thus supports the measuring function of the device.
Accessories are taken into account in the technical documentation for the medical device. The essential safety and performance requirements of Annex I of the MDR must be met by the accessories in the same way as by any medical device.
