Is EMC + Radio Re-Test Required?

[Fred1977]

Hi,
I have a medical product that incorporates a bluetooth module for comms with a host PC, and a dongle that plugs into the host PC that also incorporates a bluetooth module. Previously we paid $6K for EMC and radio testing (for emc, EN301 489-1 v1.9.2, EN 301 489-17 v2.2.1, EN60606-1-2, and for radio EN301 328 v1.8.1).

I've had to replace the bluetooth module in both unit and dongle with one from a new manufacturer (it's pre-certified), with some very minor changes to the PCB to accomodate the new module - do I need to repeat all the costly testing above, a subset of it, or none of it?

I thank you very much in advance for any input.

 

[Peter Selvey]

It is kind of the wrong way to look at it.

Instead of saying "do I need to retest?" you should be asking "is the old test data representative of the new version?"

Legally, you must always have evidence to support the actual marketed device, including newer versions. It is OK to use or refer to test data on previous versions, but it is not so much a decision about re-test but a decision whether the old data is representative of the new device. If yes, the old data formally becomes the evidence for the new device.

This should be documented, and the person making the decision should be suitably qualified and not subject to undue conflicts of interest (especially, for medium to high risk devices).

Regulatory agencies can of course challenge the decision. But keep in mind they need objective evidence that the original decision was wrong. If the manufacturer wrote up a reasonable rationale, and the person writing was clearly qualified, they need more than just a blind "we don't agree". They will need to point at the technical mistake in the logic or justification.