Accessory to medical device or not?

[SamKD]

Hi, I have a question regarding our medical device being an accessory to a medical device or a medical device in itself.

We are developing a robot to fully automate a throat swab and to achieve this our robot consists of several AIs and mechanical parts.

Since our product can not fulfill its intended purpose without a swab stick, is it then an accessory to the swab stick? Furthermore, we assist the swab stick.

Until now we have categorized it as a medical device in itself belonging to the non-invasive active device class I.

According to MDR, I have underlined an interesting line:
(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

 

[KShaw]

You might want to consider your robot and swab as a system, rather than as individual products. The intended purpose of the system would be to take throat swabs. In this scenario, the swab itself can be considered a consumable component of your system. The system would then take on the highest classification of the individual components.

With that said, whether or not it is an accessory will change little in terms of the requirements to be met.

Best of luck!
Ken