100% Final Inspection Requirements of Active Medical Devices (MDD or IEC Standards?)

[sriramsl]

Request the experts to advise me, where does the MDD or IEC standards mention that Active Medical Devices have to undergo 100% Final quality inspection. Or is it possible to perform sample inspection (Final quality inspection)

 

[Sarah Stec]

Re: Inspection of Medical Device

I'll leave the IEC standards to the experts, but the MDD doesn't require 100% inspection unless the conformity assessment the manufacturer chooses is Annex IV. Section 5 in Annex IV requires the manufacturer to examine each product individually to verify the conformity of the products.

 

[dgrainger]

Re: 100% Final Inspection Requirements of Active Medical Devices (MDD or IEC Standard

Annexes II, V and VI require 'final inspection' if that's what you mean?

 

[sriramsl]

Re: Inspection of Medical Device

I'll leave the IEC standards to the experts, but the MDD doesn't require 100% inspection unless the conformity assessment the manufacturer chooses is Annex IV. Section 5 in Annex IV requires the manufacturer to examine each product individually to verify the conformity of the products.

Thank you very much for our reply.
We are taking the Full Quality assurance under Annex II, and under OBL. 100% inspection is done by our OEM, So am I to understand that we can do only sample inspection, as defined by us as a OBL?

 

[Sarah Stec]

Re: Inspection of Medical Device

Thank you very much for our reply.
We are taking the Full Quality assurance under Annex II, and under OBL. 100% inspection is done by our OEM, So am I to understand that we can do only sample inspection, as defined by us as a OBL?

This depends on a few different factors. What does your final inspection procedure say? Is the batch or lot you receive from your OEM big enough to justify sampling? Have you had problems with this OEM such that you need to double-check that their 100% inspection is good? Even though they do 100% inspection, you are still legally responsible for the product placed on the market , even under your OBL name. So, looking at all the factors, if you can justify sampling, then it may be OK.

OBLs aren't defined in the MDD (as far as I can remember), so you should treat this justification as though you are the legal manufacturer (which you are, even as OBL).