Article 22 Procedure Pack Labelling

[Spikey47]

Hi, I'm new to the forum and hoping that we can share some knowledge of the requirements for procedure pack labels under Article 22.
I'm working with a company that buys CE Marked components (could be 40 per pack), combines the components into a pack and sterilises the pack. The majority of the packaging is removed (with the approval of the Legal Manufacturers) prior to sterilisation.

Up until now, we have transferred very little information from the primary packaging of the components onto the procedure pack label however we have recognised that we need to correct this. The contact details on our current label is limited to our details (procedure pack company).
What are the thoughts around the requirements for procedure pack labels?

Should we be including the name and address of the legal manufacturer on the procedure pack label? Considering that we could have up to 40 components, this will be quite a challenge to include them all.

Also what about the EC representative details for those components that are originating from outside the EU, should these details be included?
I guess if we were to take a risk based approach and ask what is the risk involved in not including the LM details, the risk is that the customer does not know who to contact in the case of a vigilance incident.

Is it justifiable that in the event of a vigilance incident, that the customer is able to contact us as the procedure pack company? We have processes set up for handling customer complaints and forwarding to the relevant Legal Manufacturers so there's no risk from that point of view.
I'd appreciate any feedback from people working in this area and see what their experience has been.

 

[Marc]

Thanks in advance to anyone who can help with this.

 

[L_O_B]

Hello Spikey,
I would really like to provide a more satisfying answer, but I think you have quite a problem there.

As described in Article 16(1,a) a natural or legal person shall assume the obligations incumbent on manufacturers, if it makes available on the market a device under its name, registered trade name or registered trade mark. Same applies for modifications of a device already placed on the market in such a way that compliance with applicable requirements may be affected
Even if you have an agreement with all manufacturers that you may remove the packaging use your sterilisation procedure and you have proof that this does not affect the devices' safety and performance, you are not allowed to remove the accompanying information.
The information was added by the manufacturer to comply with annex I chapter III. You must not omit any of the information previously provided by the manufacturer. This includes obviously the contact details of the manufacturers and ARs but also warnings, precautions and each UDI carrier. Otherwise you will be seen as the manufacturer.

 

[Spikey47]

Hi LOB, it’s really good to get your perspective on this. Many thanks for your response, however, I disagree on this. This is common practice within the EU and there are many companies performing these activities. I am aware of Article 16 and cannot agree with this interpretation.
Article 22 acknowledges that procedure packers can sterilize procedure packs – but based on your argument, would this not also be considered to be a modification of a device which could affect it’s compliance with requirements? If so, why is Article 22 specifically outlining it as an activity performed by procedure packers and does not require that the procedure packer must take on the responsibilities of a Legal Manufacture and CE mark the procedure pack as a device in its own right?
If the LM gives approval for the procedure packer to place the device in a pack with their CE mark displayed alongside their product name and if they agree that the packaging can be removed prior to sterilization then Article 16 does not apply to procedure packers.
In this case, the LM must be in agreement that these activities do not affect compliance with applicable requirements (otherwise they could not give approval), and therefore it is up to the LM to justify in their technical file that the devices supplied to procedure packers are in compliance with the applicable requirements – they can validate this by requesting copies of the procedure pack labeling to check what information has been brought onto the pack label or by auditing the Procedure packer, there are many ways to validate this, but ultimately it is up to the LM to justify this to their notified body IF they sign an Article 22 agreement and provide approval for the packaging to be removed.
The notified body for the sterilization of the procedure pack will want to see that the procedure packer have Article 22 agreement with the suppliers, they have approval to remove the packaging and that they have transferred any relevant information to the PP label. The process to determine the relevant information is what we are working through right now.

 

[L_O_B]

I was not trying to say, that you are not allowed to unpack the devices.
The (re-)sterilisation process has without a doubt the potential to affect the compliance of the devices. But as you mentioned it is also common practice. That is the reason why they added this option to article 22 and made the involvement of a notified body obligatory.
So far, this is fine for the sterilisation part.
Regarding the accompanying information, there are still issues. According to article 22 you must draw up a statement that you "supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products".
You cannot omit information that was intended by the manufacturer for the user. This includes at least all information that is required by annex I 23.1-23.4. If you do this, the device is no longer in compliance with the regulation.

 

[StepPCHen]

What Classification are the Procedure Packs? If class I or IIa you do not need to provide IFU.