'Distributor' definition & MDR/MSR relationship

[Lorna21]

Hi all, I was hoping to get your thoughts on the definition of a distributor under MDR and how that relates to the definition of a 'distributor' vs 'fulfilment service provider' in terms of the Market Surveillance Regulation EU 2019/1020 (MSR)?

We are currently using the services of a company to warehouse and pick, pack & ship product for us on the continent. Per the MDR I believe that this company meets the definition of a distributor i.e. they are a part of the supply chain that makes medical devices available on the market. This company however is wanting to reclassify themselves as a 'fulfilment service provider' as defined in the MSR.

As I understand it, this company wanting to call themselves a 'fulfilment service provider' under a different regulation has no bearing on the fact that they are a 'distributor' as defined in the MDR, and therefore obliged to meet all of the obligations of a distributor as defined in the MDR.

Furthermore, MSR (4) states "However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 ( 3 ), (EU) 2017/745 ( 4 ) and (EU) 2017/746 ( 5 ), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 ( 6 ) of the European Parliament and of the Council".

Doesn't this mean that the provisions of the MDR trump any provisions of the MSR?

If there's anyone out there who has had experience with this I'd love to hear your thoughts.

Thanks so much.

L

 

[L_O_B]

Hi Lorna21,

This is not as easy as it may seem. To be considered a distributor under the MDR, the entity must make the device available on the market.
According to the Blue Guide
"The making available of a product supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right concerning the product in question after the stage of manufacture has taken place. The transfer does not necessarily require the physical handover of the product.
[...]
Transfer of ownership implies that the product is intended to be placed at the disposal of another legal or natural person."
I would assume that the warehouse is not offering the device to the customer. I would also assume that you provide an offer or enter into an agreement with the customer directly. Afterwards you tell the warehouse where to deliver the device. Even though physically the devices are located at the warehouse, the ownership remains with the manufacturer. The transfer of ownership takes place when the customer accepts your offer and the ownership is directly transfered from you to the customer. The warehouse never owns the device. Therefore, they cannot be a distributor.

Sadly, the regulators did not add fulfilment service providers and respective tasks to MDR/IVDR. In my eyes, this was a failure.
But, I agree with your warehouse and their interpretation that they are not a distributor.

A little reminder: By involving a warehouse to "pick, pack & ship" your devices you outsourced activities. You must have control over these activities.

 

[Lorna21]

Hi L_O_B,
Thank you so much for your reply! I have to say that I disagree with your statement that "To be considered a distributor under the MDR, the entity must make the device available on the market."
As I read it the MDR does not say that the distributor 'must make' the device available on the market. It defines a distributor as being "any natural or legal person in the supply chain...that makes a device available on the market, up until the point of putting into service"

Though there is no transfer of ownership of the devices from the manufacturer to the warehousing facility, by virtue of the fact that the warehousing facility take possession of the devices and then ship those devices to a downstream distributor, they are in fact a member of the supply chain making those devices available on the market. Therefore, being a part of that supply chain, they are a distributor per the MDR definition.

Please let me know what your thoughts are on that arguement?

Thanks,
L

 

[L_O_B]

that makes a device available on the market

You even quoted the part. You cannot be a distributor, if you are not making available a device. Fulfilment service providers are members of the supply chain, but according to the clarification on the topic "making available on the market" as part of "Information from European Union institutions, bodies, offices and agencies", this kind of supply is not considered making available on the market.