Recall - Is there a European regulation for recalls of products

shimonv

Trusted Information Resource
#1
Hi Fellows,
Is there a European regulation for recalls of products which are unlikely to cause injury or illness, something like FDA Class III recall?
I am not aware of one and it seems to me that any such activity should only be documented internally in the complaint / CAPA files without involving the NBs.

Your thoughts?

Thanks,
Shimon
 
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Miner

Forum Moderator
Staff member
Admin
#2
Governmental regulations for recalls cover the requirements for those situations where you MUST initiate a recall. In situations where no such recall is mandated, a company may develop and follow internal processes.
 

Jean_B

Trusted Information Resource
#3
The current medical device specific legislative document in effect is guidance Med Dev 2.12-1 rev 8 (of which you would already be aware knowing your history). I also know of nothing else in effect at the moment.
Under 5.4.4 it states "Removals from the market for purely commercial non-safety related reasons are not included." and "The Medical Device Directives require the MANUFACTURER to report to the National Competent Authority any technical or medical reason leading to a systematic recall of devices of the same type by the MANUFACTURER. Those reasons are any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or USER or to a serious deterioration in his state of health."
Going by the guidance then even negligible risks (US FDA class III equivalent) would need to be administered as EU FSCA's. It is only when safety is not involved in the decision where you would not need to maintain anything.

Then the route becomes do or do not based on an assessed need "In assessing the need for the FSCA the MANUFACTURER is advised to use the methodology described in the harmonised Risk Management standard EN ISO 14971: 2000. In case of doubt, there should be a predisposition to report and to undertake a FIELD SAFETY CORRECTIVE ACTION."
This you could just as well model on the Health Hazard Evaluation process of the US FDA (enhanced with the guidance from US FDA's "Distinguishing Medical Device Recalls from Medical Device Enhancements"). Include a section where a determination is made whether any safety/performance related reason is still present for the recall (include the clinician/clinical expert in the sign-off). If yes then FSCA ; if no then execute per organization-specific process (Why though, see below). And at least you documented your reasoning and justification should anyone wonder later.

This does not really fit within the (quality) complaint files in any case, as the substantiated deficiencies there are practically always tied to Essential Requirements/General Safety&Performance Requirements, or if they're not substantiated why waste any resource on them? CAPA could be it, but then it should be based on a deviation/non-conformity against something else than the Quality Management System (The environmental one? The energy one? They end up being quite similar anyway.)
But likely you'll be doing the same as your existing process, excepting without the notification/authorization of external parties. Waiver its abberant use by management with the non-safety rationale of the HHE, standardize an alternate route for such cases if the frequency increases. One process less is better, and any kind of recall/withdrawal/stock recovery/stock rotation is worth doing well so if you trust an existing process, use it.

Why the QMS reasoning/justification record and waiver advise? When it comes to the EU Medical Device Regulations it is once again annoying (and inconsistently used) definition time for 'corrective action', the apparent sub-type 'Field Safety Corrective Action' and even undefined but still used 'preventive action'. I'm not burning time on an interpretation of these as they're quite tangled up, but the pragmatic inspection people will likely model the intent of the above to mirror the clearer FDA approach and expect similar. If you do it out-system, well you're out system. If you don't have it even worse. Best weighed approach is in-QMS administration and control. Specifics could be weighed, and if found wanting, the corrective action is lighter as it is only removing the exceptions.
 
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