Medical Device component - Validate or not validate?

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

I have a customer that is building a medical device. They want our non-medical device to be a component of their medical device. Is our device required to be manufactured under GMPs and thus be validated also?

Thanks in advance,
Steve

2

It depends. Your customer should be telling you the manufacturing requirements and under what conditions they will accept product.

However, they have the responsibility to show that their device is safe and effective when using your component.

The regulatory language gets rather vague. According to the language, an accessory to a device is, itself, considered a medical device and would thus need to comply with GMPs. In practice, though, it’s difficult to know how / where to draw the line (that’s why regulatory consultants get the big bucks!). But again, that decision needs to be on the medical device manufacturer (your customer) and they need to define what requirements to flow down to you, if any.