Guidance Documents on how to manage a Recall as well as on Limits of Rework

M

maryacton

#1
Hi folks

I would really appreciate if any of ye have any Guidance documents on how to manage a Recall situation for the medical device industry and if there is Guidance on the Limits of Rework? I’m not even sure if such Guidance exists but if it does and ye know where to direct me to source it I would really Appreciate it.

Thanking you in advance for your continued support on my constant bombardment of seeking Regulatory Info.

Regards
 
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R

Roland Cooke

#2
Re: Guidance documents on how to manage a Recall as well as on limits of rework?

The relevant MEDDEV has just been updated, make sure you implement all key elements into your procedures.

To test the effectiveness of your recall procedures (and to provide evidence of implementation) I tend to recommend that companies perform a mock recall every now and again.
 
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R

robertjbeck

#3
Re: Guidance documents on how to manage a Recall as well as on limits of rework?

thanks for the link. I do not find these kinds of general links helpful, since I do not know the specific document or web page to locate - it looks like it might point to something that would list or describe "key elements." As someone who works at a Notified Body, you know a lot more about this than the rest of us so it's second nature for you to use such a link.
 
R

Roland Cooke

#4
Re: Guidance documents on how to manage a Recall as well as on limits of rework?

Well it's been four years since I posted the general link. That was probably the right thing, as those documents get updated very fairly frequently.

However it could be that the weblink isn't taking you to the list of MEDDEVs, rather the front page for the Commission. :confused:

The MEDDEV detailing recall action is 2.12/1 (also see the others under 2.12).

You can Google MDD MEDDEVs, that also works well.
 
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