FSN for regulatory breach

JoCam

JoCam

Trusted Information Resource
#1
#1
Hi All,

So, during the mammoth task of updating all class I medical device documentation to confirm MDR compliance one or two products slipped through the net and continued to be sold. These are fully tested, safe and effective but do not have a clinical evaluation report or GSPR checklist, and MDR is not referenced in the technical file. A breach of the regulations yes, but as there is no safety issue what should be included in the FSCA and resultant FSN as to the reason for the recall of these products requested to be performed by the competent authority?

JoCam
 
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Philip B

Quite Involved in Discussions
#2
#2
So, your competent authority have requested that you recall perfectly safe products due to some missing paperwork? Have you challenged them on this?
 
Raisin picker

Raisin picker

Quite Involved in Discussions
#3
#3
It seems the competent authority has requested to recall products for which there is no valid proof that they are safe. This is in their job description.

You have to look at both sides of the medal.

But still, Philip is right, you might want to try to solve this without FSCA, when you can provide the required documentation quickly (for class I, when no NB is involved).
 
JoCam

JoCam

Trusted Information Resource
#4
#4
Philip B said:
So, your competent authority have requested that you recall perfectly safe products due to some missing paperwork? Have you challenged them on this?
Click to expand...
Hi Philip,

I have held a meeting with the CA and challenged the decision, but they are adamant that the devices must be recalled as there has been a breach of the regulations. At the point of sale there was valid proof that the devices are safe and effective, but due to the missing paperwork no valid proof that we had fully complied with the MDR requirements.

We'll take it on the nose, but I don't wish to mislead customers with the reason for the recall that needs to be in the FSN. I don't want the end users of these devices thinking that they have to urgently stop using them because they are unsafe, which could leave them without the equipment they desperately need.

JoCam
 
P

Philip B

Quite Involved in Discussions
#5
#5
Hi JoCam, FSNs can take many guises so you need to find a form of words that satisfies the CA whilst not spooking your customers. Your CA might allow you say that the FSN is purely precautionary due to a regulatory issue and that there is no patient risk for devices already used. Best of luck with it.
 
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