Does OEM/OBL-Relationship need to involve an EU Authorized Representative?

[Kh_Nadja]

Hello everyone!

Company I work for is a medical device manufacturer established in the EU (let's call it "Company A"). We are going to enter into OEM-collaboration with a company located outside the EU ("Company B"): the idea is that they will obtain a CE-mark and start producing a device that we, Company A, will be selling in Europe under our name. So, in terms of MDD we will act as a legal manufacturer of this product.

This product makes sense only if we, Company A, sell it (it is an accessory to another device that we own), the original manufacturer has no use of it otherwise.

Company B is already selling a range of other products in the EU and has an authorized representative on the European market.

The question is - does their authorized rep need to co-sign the declaration of conformity for this item, even if they will not have to perform any duties on the EU market? This seems a bit unnecessary, because no one except Notified Body and Competent Authorities will ever know that Company B produced it, as we are the legal manufacturer and take care of the regulatory part ourselves.

Could anyone please help me with this?

 

[somashekar]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Short answer is yes. The regulatory is not concerned with how you do business.
Company B has the CE mark for that device, and they are out of the EU. The EU AR is involved.

 

[Ronen E]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Company I work for is a medical device manufacturer established in the EU (let's call it "Company A"). We are going to enter into OEM-collaboration with a company located outside the EU ("Company B"): the idea is that they will obtain a CE-mark and start producing a device that we, Company A, will be selling in Europe under our name. So, in terms of MDD we will act as a legal manufacturer of this product.

This product makes sense only if we, Company A, sell it (it is an accessory to another device that we own), the original manufacturer has no use of it otherwise.

Company B is already selling a range of other products in the EU and has an authorized representative on the European market.

The question is - does their authorized rep need to co-sign the declaration of conformity for this item, even if they will not have to perform any duties on the EU market? This seems a bit unnecessary, because no one except Notified Body and Competent Authorities will ever know that Company B produced it, as we are the legal manufacturer and take care of the regulatory part ourselves.

As the legal manufacturer you need an EC certificate, regardless of whether the actual manufacturer (OEM) has one. Since you are located inside the EU you don't need an Authorised Rep. The OEM (company B) AR is irrelevant.

As much as I understand the "old" OBL CE marking arrangement is practically discontinued and you will most likely be unable to benefit from it. You will need to obtain the EC certificate just as if you were the actual manufacturer. Since you aren't, you will need the full support of the OEM.

Cheers,
Ronen.

 

[Kh_Nadja]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thank you Ronen for your reply!

Could you please elaborate in more detail about the current practice around OBL arrangement and what it means that it got discontinued?

I read about the trend of tightening up the controls over OBLs after PIP-implant scandal, but I thought the ultimate result was that OBLs now are required to keep full technical file (instead of a summary, as it was before), and that the review of the full file was the ultimate measure, which normally would not be required. But are the things even worse?

 

[fialor]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thank you Ronen for your reply!

Could you please elaborate in more detail about the current practice around OBL arrangement and what it means that it got discontinued?

I read about the trend of tightening up the controls over OBLs after PIP-implant scandal, but I thought the ultimate result was that OBLs now are required to keep full technical file (instead of a summary, as it was before), and that the review of the full file was the ultimate measure, which normally would not be required. But are the things even worse?

Kh_Nadja
Short answer:
They do not need to as they should not be CE marking unless they have a commercial reason.
You will hold all the documentation because OBL as we knew it is dead.
Long Answer:
The "old" OBL structure allowed a manufacturer to essentially re-label a product already on the market as its own, effectively "piggy backing" off of the original manufacturer’s CE mark.
The trend now, and it will be more tightly controlled with the new MDR, is that the OBL route of "piggy backing" no longer apply. Your NB will require that as the Legal Manufacturer you hold all the required technical documentation or have access to it (my notified body interpreted the later to mean onsite when we ask for it).
Whereas the "old" trend was to hold a top-level STED and refer to the CE mark that the original manufacturer held, plus there was no onsite requirement for the OBL.
With the Legal Manufacturer of the re-labelled product needing to hold all the technical documentation, it negates the need for the OEM to CE mark their devices, unless of course they have a commercial reason to.
That is not say your OEM cannot CE mark their device; they can and it might make it easier for you to access the required documentation for your technical file.
If they do want to CE mark the device, they will need the EU AR to be responsible as they will be selling you (placing on the market) a finished medical device and not a component.
For clarity, the MDD does not require the EU AR for a commercial contract for a product they do not place on the common market.

 

[Ronen E]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

as they will be selling you (placing on the market) a finished medical device and not a component.

I'm not sure that this is correct. Company A will be the EU importer in that scenario, and sale to the importer is not (as far as I understand the term) considered Placing on the Market. Rather, it's the first sale made in the EU, ie by the importer. This is how I read the Blue Guide, but I might be wrong.

 

[fialor]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

I'm not sure that this is correct. Company A will be the EU importer in that sacenario, and sale to the importer is not (as far as I understand the term) considered Placing on the Market. Rather, it's the first sale made in the EU, ie by the importer. This is how I read the Blue Guide, but I might be wrong.

Thanks Ronen E.
The Blue Guide states
"— A product is placed on the market when it is made available for the first time on the Union market.
— Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market."

In my experience unless the sale to Company A happens outstide of the EU, it will be an EU sale and therefore the placing of the market definition applies.

I am happy to hear others' experiences.

 

[Ronen E]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thanks Ronen E.
The Blue Guide states
"— A product is placed on the market when it is made available for the first time on the Union market.
— Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market."

In my experience unless the sale to Company A happens outstide of the EU, it will be an EU sale and therefore the placing of the market definition applies.

I am happy to hear others' experiences.

If the seller is based outside the EU and the buyer inside, does the sale happen inside or outside the EU?

I vaguely remember that there are some examples in the Blue Guide and I think that that was where my opinion originated.

 

[L_O_B]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

The Blue Guide says that only manufacturers and importers may place products on the market. Every subsequent distribution is called making available. Therefore the delivery of a device from a third-country manufacturer to a legal or natural person inside the EU is not yet deemed to be placing on the market.
The legal or natural person receiving the device first is now the importer and may place the device on the market.
As far as I understand it

 

[Kh_Nadja]

Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Just found a European Commission guidance regarding the interpretation of the term "placing on the market" (attach it to the post in case anyone could also find it useful). It says:

"Under certain circumstances, however, the placing on the market of an imported medical device does not coincide with its release for free circulation, namely in cases where that product has not yet been transferred from the stage of manufacture to the distribution stage. For example, this would be the case ...
- where the product is transferred to a manufacturer’s (or the authorised representative's) warehouse as long as the product is not yet made available on the market. This includes the case where the goods are stored in the warehouse of a European manufacturer who has the product designed and manufactured outside the EU and markets it under his own name or trademark in Europe."

So, as Company A is a legal manufacturer, it is this company who places the device on the market, so I would guess that the EAR should not be involved. :