Certified Body Audit of MDR requirements

JoCam

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#1
Hi All,

Can a certified body formerly designated to the MDD, but who have declined to be designated to the MDR, still audit against the requirements of the MDR during an ISO 13485 audit.

Jo
 
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Sidney Vianna

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Staff member
Admin
#2
As I see it, ISO 13485 is strict on product regulatory compliance. Since the MDR is a regulation for medical devices to be marketed in Europe, the CB is within the scope of the audit if they assess how the QMS is structured to deliver on the objective of product compliance, so, yes, the CB should be able to assess relevant requirements to ascertain the organization's ability to comply with the MDR.
 

Watchcat

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#3
Anyone can audit against the requirements of the MDR (or any other requirements), if they are so inclined. Usually they would not be so inclined, unless someone were to pay them to do it. Whether someone will pay them to do it depends on whether they see value in it.
 

yodon

Staff member
Super Moderator
#4
Certainly they can, but it may not be that valuable. If you use those results somehow to demonstrate compliance to the MDR for CE marking, it likely won't be accepted.

@Sidney Vianna - for the sake of discussion, why wouldn't they also audit to ANVISA (Brazil) requirements, TGA (Australia) requirements, Health Canada requirements, etc.? I believe all those expect a foundation based on 13485. (Maybe JoCam's products aren't sold in those jurisdictions?) It also gets me wondering about things like GDPR.
 

Sidney Vianna

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#5
@Sidney Vianna - for the sake of discussion, why wouldn't they also audit to ANVISA (Brazil) requirements, TGA (Australia) requirements, Health Canada requirements, etc.?
Any RELEVANT product regulatory requirement would be part of an ISO 13485 audit. But, let's remember, an ISO 13485 audit is a system audit, not a product inspection. Nevertheless, the auditor might assess how the system is structured to deliver a conforming product by assessing parts of applicable regulations and how the organization is addressing them.
 
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