Repackaging and translation under MDR

[Stilts]

My company wants to import Medical Device from china to EU, Chinese manufacturer declares that they are Class I single-use Medical Device and they have an Authorized Representative in the EU

We want to buy this Product packed in a collective box, without markings and instructions, which it is not intended to be delivered to the target customers.

In our company, we plan to repackage these products to unit packages in which they will reach target customers in various quantity variants.
We want our brand logo to be displayed on the Product and on the packaging. In addition, in the middle of the box, we want to put the instructions for use in different EU languages and from outside the EU, because we want to export this product also to countries outside the EU.

I am completely new in Medical Devices, so please help me.

From the information I already have, it appears that in order to remain only an importer, we have to sign contracts in which the Chinese manufacturer will commission us to repackage and translate? Because otherwise we would have to be certified as a Notified Body in accordance with MDR Article 16 (3) and (4)?

1) We know that in order to remain an importer, we must put the details of the Manufacturer and its Authorized Representative on the packaging. Is this information sufficient on the back of the packaging, while only our brand will be displayed on the front of the packaging, without information about the Chinese manufacturer?

2) Do the information in the instructions and on the packaging have to be identical to the manufacturer's packaging (which he sells directly under his brand)? Maybe can we make an agreement with the manufacturer that we will slightly modify the content of the instructions and information on the packaging? (e.g. Add some information about the product to encourage the customer to buy)

3) In this case, if we sign a subcontract with a Chinese producer, does he have to give the product its catalog numbers and the Chinese EAN (UDI-DI)? Can we also conclude an agreement with him, thanks to which the catalog numbers will remain in our style and the EAN will be with the EU prefix?

4) Am i right that, the name of the product cannot be translated into other languages? Must remain as on the declaration of conformity? But is it possible to add "product type indication" in different languages?

5) In that case, if we translate the information on the back of the packaging and the instructions into, for example, 7 EU languages, then, according to MDR, we must have all the information on the front in 7 languages (e.g. product type or some information about the product encouraging the customer to buy)? Can we only provide this information in e.g. two languages? Or only include them on the back of the package? Taking into account Article 10 (11) (and Annex I para. 23.2 to which reference is made).

6) Can we put exactly the same information on one package that the device is a medical device in a language from outside the EU and export these products to markets outside the EU where this device is not registered as a Medical Device? Maybe we can only change the content of the information in a given language, but the packaging will remain the same?

7) In the case of signing contracts in which we translate / repack at the request of the Manufacturer, do we also have to have internal procedures regulating these processes?

8) Should we use professional translators when translating "on behalf of" the producer? Can we use our own language skills?

I would appreciate your help!

 

[Junn1992]

while only our brand will be displayed on the front of the packaging, without information about the Chinese manufacturer?

According to MDR, if you use your own brand, you become the manufacturer and assume responsibilities of a manufacturer under the MDR.

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

2) Do the information in the instructions and on the packaging have to be identical to the manufacturer's packaging (which he sells directly under his brand)? Maybe can we make an agreement with the manufacturer that we will slightly modify the content of the instructions and information on the packaging? (e.g. Add some information about the product to encourage the customer to buy)

Yes this is OK. BUT, subject to what is mentioned above.

3) In this case, if we sign a subcontract with a Chinese producer, does he have to give the product its catalog numbers and the Chinese EAN (UDI-DI)? Can we also conclude an agreement with him, thanks to which the catalog numbers will remain in our style and the EAN will be with the EU prefix?

Not really, if you market under your own brand, you become manufacturer. As such, you need to register an EU UDI for the product which is held by your company.

4) Am i right that, the name of the product cannot be translated into other languages? Must remain as on the declaration of conformity?

Yes

But is it possible to add "product type indication" in different languages?

what do you mean product type indication? Normally it just indicates the product is a medical device

6) Can we put exactly the same information on one package that the device is a medical device in a language from outside the EU and export these products to markets outside the EU where this device is not registered as a Medical Device? Maybe we can only change the content of the information in a given language, but the packaging will remain the same?

This is a bit tricky as there might be problems during importing into the EU. For re-export, do not see a problem.

7) In the case of signing contracts in which we translate / repack at the request of the Manufacturer, do we also have to have internal procedures regulating these processes?

Yes, there are specific requirements in the MDR for this.

8) Should we use professional translators when translating "on behalf of" the producer? Can we use our own language skills?

You can do it in-house, no problem, but you better make sure it does not affect the sales/marketing side. Which is why professional translations are always recommended, starting with english version as a base.

For question 5, you might not need 7 languages on the packaging, but definitely in IFU.

 

[Stilts]

Thank you Junn1992 for your answer.

According to MDR, if you use your own brand, you become the manufacturer and assume responsibilities of a manufacturer under the MDR.

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

Does Article 16 (1a) not apply here?

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

 

[Junn1992]

Thank you Junn1992 for your answer.

Does Article 16 (1a) not apply here?

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

This is a tricky one, because you intend to sell under your own brand name. IMO, Article 16 applies IF you sell under the manufacturer brand name, and you only label yourself as the importer.

 

[Stilts]

This is a tricky one, because you intend to sell under your own brand name. IMO, Article 16 applies IF you sell under the manufacturer brand name, and you only label yourself as the importer.

I don't think this art 16(1a) speaks of it.
Importer don't need an agreement with the Manufacturer to mark yourself as an importer on the product. Acturally it is the importer's obligation to label oneself on the device acording 14(3):

3.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.

 

[Cybel]

Does Article 16 (1a) not apply here?

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

I think it applies.

I’m comparing your situation to mine.
Consider that we are EU manufacturer, so we don't have importers but we have distributors; however, I think that the situation is similar, for what may concern this issue in particular: we = the Authorized Representative of your Chinese manufacturer and you = our distributor.

We sell the device under our brand, but in some cases distributors want to market the device under their own brand, like you want to do. In this case, in order to do this, I need to apply with my NB to extend my CE certificate to the new brand: this is the result of the "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"

 

[Junn1992]

I need to apply with my NB to extend my CE certificate to the new brand

you can have multiple brands on one certificate!? how does that work

 

[Cybel]

My MDR certificate includes a table where, for each model, it is indicated the trade name(s) and the trade mark(s), which can be the trademark of manufacturer or other trademark.

 

[Stilts]

I think it applies.

I’m comparing your situation to mine.
Consider that we are EU manufacturer, so we don't have importers but we have distributors; however, I think that the situation is similar, for what may concern this issue in particular: we = the Authorized Representative of your Chinese manufacturer and you = our distributor.

Yes, it's a similar case! Fortunately in our case Notify Body isn't involved.

So Cybel, (or anyone else). Please, can you answer to my questions from the first post? How you and your distributors solve these issues?

This is a bit tricky as there might be problems during importing into the EU. For re-export, do not see a problem.

Why do you think there might be problem during importing into the EU?

 

[Junn1992]

Why do you think there might be problem during importing into the EU?

From what I understand, you should have the EU label ready at the time of import.