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Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number)

K

katastic

#1
Good Morning,

I am wondering if anyone out there can help me out. I work for a small Surgical Instrument company in Colorado. We just had a review of our Technical File by our Notified Body so we can self certify our Class Ins instruments. One the report given to us by our Notified Body, one of the findings was that we needed to add the "Lot" number symbol to our labels (I'm assuming along with the lot number of the instrument) However, I am trying to find out if this is a requirement for Class Ins instruments. All I can find or gather from the MDD is

13.3. The label must bear the following particulars:

(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;

(b) the details strictly necessary for the user to identify the device and the contents of the packaging;

(c) where appropriate, the word 'STERILE';

(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;


It indicates "Where appropriate" but I have searched and searched to try and find what is deemed "appropriate" and I just need a reference to a applicable standard, that I can reference. I hope all that makes sense and I appreciate any help that can be given.

I am new to the world of Medical Devices, so I may be coming back with more questions.

thank you
 
M

MIREGMGR

#2
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

I'm not aware that there is a formal definition. I think the common understanding is that it's "appropriate" when the production process is batch/lot oriented.
 
K

katastic

#3
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

thank you. I would say that the batch/lot situation doesn't apply to what we sell, all non sterile reusable, low risk, class I instruments. We are an overbrand relabeler and don't do our own manufacturing. Am I correct in my assumption that it wouldn't apply?
 
M

MIREGMGR

#4
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

I'd think you'd want to batch code your products...either with the actual maker's batch code if that's known to you, for instance from their production documentation provided to you, or in regard to your purchase lots.

If you have an issue or event that results in a Recall, and you are not batch coded, FDA and possibly EU authorities will expect you to recall all products from a long period of time surrounding when the incident-creating product unit was thought to have been made. If on the other hand your products are batch coded, you only have to Recall the suspect batch plus any other batches that investigation shows probably have the same issue.

To answer your direct question: obviously your NB auditor thinks that you need to so label. If I were the auditor, I'd probably agree. My view is that everything should be batch/lot coded. I'm hard pressed to think of a production process that doesn't have some characteristic that can be recorded to indicate batch/lot. Even a continuous process can be date- or date/time-marked, as is common in pharma and food production.

Note that as the CE Marking party, you are the Manufacturer (or Specification Provider, which is regulatorily equal) in US FDA terminology or the Own Brand/Private Label Manufacturer in MHRA Bulletin 19 MDD terminology, i.e. the primary regulatorily responsible party, irrespective of who actually fabricates the products. Thus your "overbrand relabeler" comment is misleading.
 
Last edited by a moderator:
K

katastic

#5
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

We do have lot traceability, it just isn't something that is printed out on the labels. when we get an order from our supplier with the lot number that is entered into our inventory, and copies filed of our suppliers certs, packing lists etc... If a situation were to happen, it is an easy 5 minute look up to find out the lot number from our supplier in our database. Also a 5 minute look up if we needed to find out what customers purchased the recalled item.
 
M

MIREGMGR

#6
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

If you've got the information, I very much doubt if you're going to convince the auditor that it doesn't fall under the "appropriate" qualification.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

Hello and welcome to the Cove (and the MedDev field) :bigwave:

2 things bother me:

(a) Why was a NB involved in the CE marking process of a class Ins in the first place?

(b) If you get a defective unit back from the field, with no accompanying paperwork and/or packaging, with limited and/or confused verbal information from the complaining party (it happens a lot! sometimes you don't even get the unit, you just hear about it...), and it's not lot/batch-identified (on the unit itself), how do you quickly, easily and reliably find out to what lot/batch of yours it belongs?

Cheers,
Ronen.
 
#8
Re: Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and num

Hello and welcome to the Cove (and the MedDev field) :bigwave:

2 things bother me:

(a) Why was a NB involved in the CE marking process of a class Ins in the first place?

(b) If you get a defective unit back from the field, with no accompanying paperwork and/or packaging, with limited and/or confused verbal information from the complaining party (it happens a lot! sometimes you don't even get the unit, you just hear about it...), and it's not lot/batch-identified (on the unit itself), how do you quickly, easily and reliably find out to what lot/batch of yours it belongs?

Cheers,
Ronen.
Both good questions I was about to ask!
 
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