Hi All,
Just looking for some general advice/guidance on an issue that I've come across.
I work for an ISO 13485 certified company, and have only found out that staff are re-labelling a medical device we import from the USA, as it is happening today (not ideal, I know). I've since raised a concession and raised this serious concern with the MD.
It's a class 1 medical device, with no expiry date, rather a durability warranty. The specifics of this are that we are having to remove the manufacturers barcode label (contains a lot number too), and replace this with another barcode label that states our business name and address. Note the label we are adding goes over the manufacturers details and address, and the reasoning for this new barcode labels is the requirement of a customer who is taking all the stock.
However, our replacement barcode label doesn't state the lot number. The MD who created and sourced these labels was under the impression that as we ordered X amount with 1 batch number, that this lot number wasn't a requirement on the new label. No quality or regulatory involvement until today, when I found this out.
I accept that this query may sound very amateur, but do we actually need the lot number on the medical device label?
It is no where on the device, and we know exactly were all the stock is going. Once with the customer, the barcoding system should be enough for them to trace it through their own system.
When looking online, the below sources give me concerns, and I was wondering if anyone a tad wiser than me could help
MDCG 2021-26Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746, October 2021, page 7 states:
The manufacturer’s batch number cannot be changed and should appear on the label.
MDR (page 27) states:
Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
A website called Easy Medical Device (helpful source in my opinion) also states a lot number is required on the medical device label, according to MDR.
Just looking for some general advice/guidance on an issue that I've come across.
I work for an ISO 13485 certified company, and have only found out that staff are re-labelling a medical device we import from the USA, as it is happening today (not ideal, I know). I've since raised a concession and raised this serious concern with the MD.
It's a class 1 medical device, with no expiry date, rather a durability warranty. The specifics of this are that we are having to remove the manufacturers barcode label (contains a lot number too), and replace this with another barcode label that states our business name and address. Note the label we are adding goes over the manufacturers details and address, and the reasoning for this new barcode labels is the requirement of a customer who is taking all the stock.
However, our replacement barcode label doesn't state the lot number. The MD who created and sourced these labels was under the impression that as we ordered X amount with 1 batch number, that this lot number wasn't a requirement on the new label. No quality or regulatory involvement until today, when I found this out.
I accept that this query may sound very amateur, but do we actually need the lot number on the medical device label?
It is no where on the device, and we know exactly were all the stock is going. Once with the customer, the barcoding system should be enough for them to trace it through their own system.
When looking online, the below sources give me concerns, and I was wondering if anyone a tad wiser than me could help
MDCG 2021-26Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746, October 2021, page 7 states:
The manufacturer’s batch number cannot be changed and should appear on the label.
MDR (page 27) states:
Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
A website called Easy Medical Device (helpful source in my opinion) also states a lot number is required on the medical device label, according to MDR.
