Labeling Requirements for Reusable Class II Medical Device in the EU

M

mukesh sabarad

#1
Is it mandatory to print the batch number/ lot number on the device itself especially in the case of reusable devices (ClassII) in the EU. If it is where is it mentioned?
 
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R

rclanzillotto

#2
Re: Labelling requirements...

The question is what is the required traceability of the device. If you need to trace it back to a production lot (In most cases I'd think you would) then you either need to serialize it (being able to trace it back to production with the serial no) or as you say label the lot number on the device. Best Regards. Rich
 
M

mukesh sabarad

#3
Re: Labelling requirements...

The question is what is the required traceability of the device. If you need to trace it back to a production lot (In most cases I'd think you would) then you either need to serialize it (being able to trace it back to production with the serial no) or as you say label the lot number on the device. Best Regards. Rich
Thanks for the advice. But does it say that in the MDD. Is it mandatory
 
R

rclanzillotto

#4
Re: Labelling requirements...

I'm not sure if it is explicitly stated in the MDD or not. But your notified body auditor will surely raise the issue of product traceability in conjunction with your Vigilance program. If your position is that it is not necessary, I'd be ready to support it by addressing it in risk analysis. Good Luck
 
R

Rolande Hall

#5
Is it mandatory to print the batch number/ lot number on the device itself especially in the case of reusable devices (ClassII) in the EU. If it is where is it mentioned?
In my view is that, in so far as it is possible then it is mandatory. My logic is as follows: -

MDD 93/42/EEC states at Annex I, paragraph 13.1 “Each device must be accompanied by the information needed to use it safely and to identify the manufacturer - - - -”. In the same subsection it also states “As far as practical and appropriate, the information needed to use the device safely must be set out on the device itself and /or the packaging for each unit - - - - ”.
A medical device cannot be used safely if it has been recalled by the manufacturer. It is clear that the information needed to facilitate a recall of a device has to remain with that device during many cycles of storage, sterilisation and usage. Therefore I interpret paragraph 13.1 of the MDD as requiring that, when a device is to be reused, the batch code or serial number has to be permanently marked on the device itself whenever it is practical.
 
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