Regulatory Open Forum

Hi forum,

If there are off the shelf accessories that you supply with your device, what is your obligation as a device manufacturer?

Do you treat them as your regular accessories , have compatibility /usability done with them ? Do you list them in your user manual, register them as accessories in countries?

Lots of questions here!

Begin with risk assessment - some off the shelf accessories are more critical to safety than others, with potential consequences from none to fatal.

Then some appropriate level of validation of suitability. If you're saying or implying they're good to use with your device, you'd better have evidence to support that.

The IFU generally needs to give enough information to let the users know what's compatible with the device. You can list specific accessories, or you can provide specifications for what they should choose. This also depends on the risks related to their making errors in selection.

Registration rules depend on the device type (or non-device) and the country. Approaches could include selecting accessories that already meet the country's requirements, and/or are already registered by their manufacturers, working with the manufacturers to complete the registrations, incorporating them into your device system and registering them under your own name...