CE mark on the package (procedure / system pack?)

[MarRz]

Hello. I have a question connected to the kit/procedure pack. To perform our genetic test, we need the customer's blood sample. This is collected in a glass tube, that is registered and appropriately labelled as a medical device by the manufacturer. The manufacturer packs 100 tubes in a pack and ships them in a bigger package. We take one tube from the pack and put it into our package box along with our documentation and temperature gels. This package box is sent to the doctor, who uses a glass tube to collect the blood sample.
My question is if we can/should put a CE mark on our package along with other glass tube and its manufacturer details? I read that system/procedure packs are generally not CE market. The glass tube is the only medical device in our package, so I am unsure if we can call it a kit/procedure pack. Still, it is a medical device, and we "kind of" repackage it into a different box that has our logo on the outside.

 

[kenbarlow]

Congrats! Removing medical devices from LM packaging means you are now taking on ownership as the LM, and will be accountable for all the regulatory requirements and responsibilities that come with that.

If you don't fancy taking ownership of a medical device not produced by your company, then you should consider supplying this as a procedure pack under Article 22 - where you have obligation to show LM details on insert, including CE, CE Number, relevant symbols and include IFU (where applicable). For non-medical devices, they should also be listed on insert too - without CE.

You will also need an agreement with the LM to show them what you are doing with their product. Transparency is key.

 

[Ed Panek]

Is there a reason you are doing this and not requesting the OEM a special private label agreement with you? How are you managing UDI?

 

[MarRz]

@kenbarlow, we definitely don't want to take ownership as the manufacturer. Our interpretation was that, since the glass tubes are packed by wrapping 100 of them in plastic and paper just to hold them together, and you only use one that needs to be taken out to be used, it is not repackaging. The tube is used as part of the package that we prepare.
On the second note, the package of 100 glass tubes does contain a label with appropriate markings. It could be interpreted that we do change the original package.

@Ed Panek we do not need to have our label on the glass tube, which is the reason we never considered special private label agreement. As for UDI, we do not mark anything, but through our system, we know which device (LOT) was sent where.

I have been reading more about this, and it would make sense if we classified the package as a Collection Kit (since the glass tube is IVD device), and label it with medical device data (LOT, Expiration date, temperature range, etc.).
My assumption is, that apart from that data, we must also mark the label with ourselves as the manufacturer, since we made this Collection Kit. The question is, though, do we need to register the Collection Kit as a medical device? I cannot imagine if we need to certify it with Notified Body. Can we classify it as Class A, issue DoC and just register it with local authority. Not sure if the glass tube being Class A sterile and having certificate under IVDR complicates things.

 

[Ed Panek]

I’m not strong with ivdr but a driving force behind MDR and Eudamed was accountability. If you are making a penny on this product in the EU your fingerprints are available for competent authorities to look at.