Accessory to a medical device

[LTran]

Dear all,

The scope of ISO 13845 (QMS), IEC 62366-1 (usability), MDR, FDA 21 cfr 820, and other standards for medical device is MEDICAL DEVICE. Is an accessory for a medical device required to comply with the regulations and standards for medical devices? E.g., is an accessory required to follow the Design Controls, do we need to conduct usability engineer acc. to 62366 for an accessory (alone) to an accessory?

Accessories to a medical device are not medical devices because they can not stand alone with a clinical purpose. How to handle the documentation for them? Please help. Thank you.

Kind regards,
L. Tran

 

[Ronen E]

Dear all,

The scope of ISO 13845 (QMS), IEC 62366-1 (usability), MDR, FDA 21 cfr 820, and other standards for medical device is MEDICAL DEVICE. Is an accessory for a medical device required to comply with the regulations and standards for medical devices? E.g., is an accessory required to follow the Design Controls, do we need to conduct usability engineer acc. to 62366 for an accessory (alone) to an accessory?

Accessories to a medical device are not medical devices because they can not stand alone with a clinical purpose. How to handle the documentation for them? Please help. Thank you.

Kind regards,
L. Tran

The treatment of Accessories to Medical Devices is not uniform across the board. The approach depends on the jurisdiction.

ISO 13485 is in general voluntary. It applies in general to Medical Devices, but itself won't strictly tell you whether to apply it, or to what. It's a question of context. Different companies apply it in different ways and to different extents (including cases where - strictly speaking - it's borderline applicable), according to their goals and needs.

IEC 62366 is similarly voluntary, and plays in through regulatory schemes; meaning, it's applicability depends on regulatory jurisdiction, pathway, and your choices in demonstrating compliance with regulations.

MDR - Accessories to Medical Devices (once formally qualified as such) are regulated (on their own) just like Medical Devices.

FDA - Here it's a bit more muddy. It depends on what exactly it is. Some "accessories" have their own procode, and are regulated on their own; and others are bundled together with the device(s) they serve, under the device's procode.

HTH
Ronen

 

[yodon]

Agree with @Ronen E - no clear guidance.

Step back just a bit and consider what the intent of 62366 is: does the (product's) UI promote safe and effective use? If, standing alone, there's no usefulness, it doesn't make sense to try to consider the accessory outside of the device. You should want to show that the product promotes safe and effective use both with the accessory and without.