Regulatory Open Forum

Is anyone aware of guidance regarding customer supplied components of medical devices?  For example, the device package contains a product that requires recharging but the charging cord is not provided by the manufacturer. The customer is expected to supply their own.  In some ways this is not different than the "Bring Your Own Device" strategy for certain software applications but want to ensure that there aren't other considerations around usability or the device being considered incomplete.

Thank you in advance for any insights!

Hello Anon

It's not an unusual model, so long as the risk assessment hasn't identified likely hazards around users selecting the wrong things.

From the EU MDR: "The instructions for use shall contain ... for devices intended for use together with other devices and/or general purpose equipment: - information to identify such devices or equipment, in order to obtain a safe combination, and/or - information on any known restrictions to combinations of devices and equipment"

It may be a tradeoff between annoying customers by not supplying what they need and charging them extra for required components vs being green and not dumping extra unwanted electronics on them.