New problems exporting to Germany - February 2019

[Steve_in_MT]

Is anyone else having issues exporting medical devices to Germany? For many years, our CE marked product has been "over-labeled" by our German distributor so that the Instructions For Use are in German when sold to the hospital. We've now had two shipments held up. Our distributor talked with someone at the Ministry of Health and she told him that as soon as he relabels the boxes, he becomes the manufacturer. He would then need his own CE mark, would take on the liability, and would need to submit all documentation to the Ministry relating to manufacturing processes, sterilization, etc.

She also said that the Authorized Rep in the EU is considered the manufacturer, since their name and address is on each box.

The only option she suggested, which won't help with the shipment currently being held, is for us to over-label with IFU in German PRIOR to shipping.

So my question is not whether or not translations are required--I know they are--but when they need to be applied. The auditors in our recent MDSAP/ISO audit looked at translated materials, but seemed fine with those being used just by the distributor. I realize there are country-specific rules, and is that the case for Germany? And is it true that anyone who adds a label becomes the manufacturer?

 

[Marcelo]

Is anyone else having issues exporting medical devices to Germany? For many years, our CE marked product has been "over-labeled" by our German distributor so that the Instructions For Use are in German when sold to the hospital. We've now had two shipments held up. Our distributor talked with someone at the Ministry of Health and she told him that as soon as he relabels the boxes, he becomes the manufacturer. He would then need his own CE mark, would take on the liability, and would need to submit all documentation to the Ministry relating to manufacturing processes, sterilization, etc.

True. But this is not totally easy to spot on the MDD.

You need to look at this:

(f) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

And this:

13.3. The label must bear the following particulars:

1. (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 the authorised representative where the manufacturer does not have a registered place of business in the Community;

She also said that the Authorized Rep in the EU is considered the manufacturer, since their name and address is on each box.

Not true (the AR has no legal responsibility under the MDD, but this will change under the MDR - but they still won't be "considered the manufacturer").

The only option she suggested, which won't help with the shipment currently being held, is for us to over-label with IFU in German PRIOR to shipping.

Right.

So my question is not whether or not translations are required--I know they are--but when they need to be applied. . I realize there are country-specific rules, and is that the case for Germany?

Before entering the country. This has always been the case for Europe, the problem is that people did not do it and no one (evaluator) argued with that. It's a lot more clear on the MDR.

The auditors in our recent MDSAP/ISO audit looked at translated materials, but seemed fine with those being used just by the distributor

Unfortunatelly, auditors usually have no idea how regulations work, worse when it comes to details like this.

And is it true that anyone who adds a label becomes the manufacturer?

Depends on what the regulation says. For example, the MDR is a lot more clear in this:

Article 16
Cases in which obligations of manufacturers apply to importers, distributors or other persons

1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

1. (a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation

 

[Steve_in_MT]

Thanks, Marcelo, for an excellent response...not what I wanted to hear, but I really appreciate your breaking everything down so nicely.

 

[Steve_in_MT]

I am still a little confused by the line "...fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name". So I can see if we sent a box containing, let's say, 100 unlabeled bags each containing a medical device. The distributor would then label each bag with all the necessary info, including his company name. That clearly would be labeling, and selling the device "under his own name". But if the product is already labeled (just not in German) and it is placed on the market using the US manufacturer's name, it seems the German distributor isn't meeting either requirement--he is "overlabeling" or providing additional information to an already labeled product, and it's still being sold under the original company name. Is that not the correct interpretation of that?

 

[Marcelo]

Generally, you cannot enter a country with a product unless the product conforms to the country requirements. if the label is not in German, you are not complying with German requirements.

 

[Mark Meer]

I think the rationale is as follows: Accurate labelling is considered essential to safety and correct use, so to the extent that there is translation being applied that is NOT controlled by the original manufacturer, this entity applying new labels should bear liability.

In your case, how do you confirm accurate translation? If the labelling is already translated, can you not:
- Approve the distributor as a supplier of translation services
- Request their translated labels, review and approve them
- Apply them yourself prior to shipping

It's a bit of of a headache on your end, I realize. ...but it's certainly one option.

 

[Steve_in_MT]

Thanks again Marcelo, and thank you Mark as well. It's just strange that we haven't had an issue in probably 10 years shipping to this distributor, and then suddenly two since the start of the new year. I see what you're saying Marcelo--it probably can't really be considered a label if it doesn't conform to the regs. And I think we'll follow your suggestion Mark and apply the translations here. As you say, a headache, but it's better than having shipments returned!

 

[catalina]

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