Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall?

chris1price

Trusted Information Resource
#1
Hi, whilst they are a good practice, is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall?

Chris
 
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Marcelo

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#2
Nope. AFAIK, there's no requirement to perform a mock of anything, but several mocks are a good practice (such as mock recall, mock inspection, etc.)to verify of your process performs as intended.

One interesting one if to perform a mock adverse event reporting, to verify if your process can comply with deadline requirements (several times a client finds that they cannot, in particular if the adverse event is from a country abroad).
 

Marc

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#3
Re: Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock rec

For what it's worth - In automotive it was, and I assume it still is, a requirement for some items such as airbags and several other critical parts/assemblies. As far back as the QS9000 days proof that the recall procedure worked, by way of a mock recall during the audit, was part of the registration audit as well.
 
#4
Re: Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock rec

The closest would be

Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1
Chapter 8: Complaints, Quality Defects and Product Recalls

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-08_gmp_chap8.pdf

8.30 The effectiveness of the arrangements in place for recalls should be periodically evaluated to confirm that they remain robust and fit for use. Such evaluations should extend to both within office-hour situations as well as out-of-office hour situations and, when performing such evaluations, consideration should be given as to whether mock-recall actions should be performed. This evaluation should be documented and justified
 

chris1price

Trusted Information Resource
#5
Re: Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock rec

Thanks guys, you confirmed what I thought, I just wanted to double check.
Chris
 
#6
I am wondering on how to conduct mock recall in US market specifically on medical gloves? Never had to do this before on low risk device - non sterile examination gloves.
 
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