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CAPA against Notified Body?

Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
#1
A possible commercial partner of ours asked about our MDR transition plan during their audit of our QMS. They asked us about our notified bodies MDR capabilities and I stated they have not yet received MDR approval.

I was wondering, I know it seems unwise, but would it make sense to open a Supplier Preventive Action against our NB for them to produce an MDR compliance plan timeline?
 
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Sidney Vianna

Sidney Vianna

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#2
#2
Ed Panek said:
I know it seems unwise
Click to expand...
It is!
Ed Panek said:
but would it make sense to open a Supplier Preventive Action against our NB for them to produce an MDR compliance plan timeline?
Click to expand...
In your profile, you mention that you work for a SMALL company. Do you really think that a Notified Body will pay attention to this request? You are entitled to know if they plan on becoming a MDR NB or not. But, to expect they will share their roadmap to MDR notification with you is ludicrous, in my opinion, especially when we realize the challenges and context of this migration.

And, thinking this through....what would you do if you issue this SPAR to the NB and they ignore it? Would you disqualify them? Would you lose your product notification? Talk about shooting oneself's foot.
 
Watchcat

Watchcat

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#4
#4
It may make sense, but it is unlikely to make a difference.

It would be more useful to have a Plan B in the event your NB does not receive MDR designation...ever, or in time for your products to be MDR-certified by May 2020, or by whatever date they need to be MDR-certified by, if they can ride an MDD certification past that date.

Also a Plan C, in case your NB not only doesn't receive MDR designation, but decides to close up shop after it hears this, since you can't ride your MDD certification without an NB to provide oversight.

And...sigh...a Plan D, in case your NB doesn't receive MDR designation, and another NB agrees to accept you, and then changes its mind, (apparently this has already happened once, with TUV and LRQA refugees).

Plan Z, you don't want to know. :(
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
#5
What are other people doing? How are some companies/products not going to get caught up in this bureaucratic mess through little fault of their own?
 
Watchcat

Watchcat

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#6
#6
It would seem that there is only so much you can do at this point. NBs are profit-making enterprises, and, as far as I know, there is nothing in EU law that requires them to accept business. Most companies will choose big clients who will give them lots of business over small companies that will bring them just a little.

I would also keep in mind that, just because Business Development "accepts" your business, doesn't mean that anyone in the rest of the company is going to have time to review your application...or conduct an audit, if one is needed. (This would be my first guess as to what's behind the TUV/LRQA debacle.)
 
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