ER Checklist for a Class III Medical Device - Subcontracted Manufacturer

F

fridgefraser

I am in the process of completing an ER checklist for a Class III Medical device, we currently sub contract the manufacture, packaging and QC release testing to a 3rd party who are a GMP certified site but are not ISO 13485 certified. The final batch release decision is taken by ourselves as legal manufacturer. The question I have is when completing the ER checklist and referencing method use to show conformity, I was going to state that

"XXX is manufactured under a production quality assurance management system under EN ISO 13485:2003, certified under Annex V of 93/42/EEC (MDD)" but I am being challenged by a colleague as they argue that as the sub contractor is not ISO13485 certified this cannot be stated, my argument is that as legal manufacturer we are ISO 13485 certified, we audit our sub contractor to ISO13485 we can state this?
Peoples thoughts?
 
P

pkost

Trusted Information Resource
Re: ER Checklist - subcontracted manufacturer

I don't think it is appropriate to say that the subcontractor operates to ISO 13485 when they don't - they are an approved supplier of yours that operates to GMP requirements

I would say something along the lines of:

We (manufacturer) operate in compliance with ISO 13485 requirements. As part of our supply management, all appropriate suppliers are reviewed and approved. The sub contractor that manufactures the product operates to GMP requirements and is an approved supplier to our business.

I also don't believe it is appropriate to reference Annex V of the MDD - it's a circular argument to reference the conformity assessment method which verifies compliance with the ER as evidence that you comply with the ER...
 
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