Changing the labels of a Class 1 Medical Device

This may be taking a simplistic view, but why don't you just "obtain the rights" to be the UKRP and leave the manufacturer's labelling as it is, untouched? Just add your own label (and information sheet) as the "UK Responsible Person"

ChrisM said:

This may be taking a simplistic view, but why don't you just "obtain the rights" to be the UKRP and leave the manufacturer's labelling as it is, untouched? Just add your own label (and information sheet) as the "UK Responsible Person"

Click to expand...

I don't quite understand how this helps with the current labelling query? Apologies if i've missed something obvious here (not the most knowledgeable on regulatory matters).

My understanding of UKRP, is that if my company imports a Class 1 medical device from the USA and intends to place it on the UK market, we'll need to designate a UK Responsible Person to fulfill the regulatory requirements.

This can be either to someone within our company to assume the responsibilities of a Responsible Person, or appoint a third-party organization within the UK to act as the Responsible Person on our behalf.

^
Because from what I understand from the posts made so far in this thread, I do not think you are complying with UK MDR Law by removing the original label and replacing it with your own that has "missing" information

Take a look at MHRA's Virtual manufacturing guidance - it looks like it might be applicable: Virtual manufacturing of medical devices

dgrainger said:

Take a look at MHRA's Virtual manufacturing guidance - it looks like it might be applicable: Virtual manufacturing of medical devices

Click to expand...

Agree with this - what you're doing is virtual manufacturing. Three key concerns I'd have:
1. Are you registered with the MHRA as a manufacturer and the manufacturer of this device?
2. Can you trace your lot numbers back to the original manufacturer's numbers?
3. Do you have a compliant technical file for the device?

Matt.mv said:

The company I work for, as stated this is going over the manufacturers details

Click to expand...

[Hi there - I'am trying to better understand the scenario here]

Are you becoming the 'Legal manufacture'? thus take on all the responsibility under MDR article 10? or is the customer X taking on the legal manufacture responsibility (e.g. are they adding their trade name on the packaging or modifying the stock?). Note under the MDR there is not possibility for OBL.

From my understanding...

a) If the USA manufacture remains the LM, then you become the importer of the product > who later sell it to other customers. Then the labelling cannot be changed e.g. you cannot cover the USA LM + need to include the importer (yourself) and UKRP details.

b) If the customer X wants to become the LM then their details must be on the packing as the LM + have their own UDI system + UKRP details. In this case, I belive that the USA manufacture details can be covered. However, they should keep a record of the organically barcode details for traceability purposes.

(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)

It's unclear to me whether you are intending to comply with EU MDR or only UK regulations, but from an EU MDR perspective - you need the lot number because the device must be labeled with the complete UDI in both human readable and AIDC format. The UDI consists of the DI (device identifier, eg GTIN) and the PI (production identifier, eg serial or lot number).

UK MDR 2002 also requires the LOT number to be labeled on the product, where appropriate. So even if you were following UKCA you are still not meeting the requirement. It sounds like there is a lot going on in this situation so IMO, the label is only one of several worries here for you.

Realistically, you may or may not get caught by the CA. If it is a class I low risk device...they may not waste their time. However, risk level and consequences should not be the reason you don't fix your situation here.