MDR EU Distributor for our CE Mark product in the for Netherlands

#1
Hi everyone! I work for a US company and we use a large distributor/warehouse located in The Netherlands for our CE Mark product. I don't want to mention the company's name, but they are one of the big ones and I imagine a lot of you use the same company as an EU distributor. This company is pushing back on taking on the distributor role under MDR, stating they don't meet the definition of distributor because they "don't add value to the product". It is clear to us they are a distributor making the device available under the Blue Guide.

Has anyone else received pushback from this company or maybe others? How have you handled this?
 
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shimonv

Trusted Information Resource
#2
I haven't heard of such a distributor behaviour, but keep in mind that the implementation date is almost a year from now; they'll have plenty of time to repent... They really have no choice.

Perhaps there is a business rationale for this that you are not aware. Since there are so big you can check with their other clients.

Good luck,
Shimon
 

L_O_B

Involved In Discussions
#3
Hi mickey,
depending on the tasks they conduct, they actually might not be a distributor.

See blue guide page 36:
Fulfilment houses represent a new business model generated by e-commerce. Products offered by online operators are generally stored in fulfilment houses located in the EU to guarantee their swift delivery to EU consumers. These entities provide services to other economic operators. They store products and, further to the receipt of orders, they package the products and ship them to customers. Sometimes, they also deal with returns. There is a wide range of operating scenarios for delivering fulfilment services. Some fulfilment houses offer all of the services listed above, while others only cover them partially. Their size and scale also differ, from global operators to micro businesses. The activities of fulfilment service providers as described above go beyond those of parcel service providers that provide clearance services, sorting, transport and delivery of parcels. The complexity of the business model they offer makes fulfilment service providers a necessary element of the supply chain and therefore they can be considered as taking part in the supply of a product and subsequently in placing it on the market. Thus, where fulfilment service providers provide services as described above which go beyond those of parcel service providers, they should be considered as distributors and should fulfil the corresponding legal responsibilities.

Additionally, regulation 2019/1020 added 'Fulfilment Service Provider' as an economic operator:
‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport services;

Depending on the tasks your warehouse covers and based on the ownership status of the devices, the warehouse may actually not be a distributor.
 
#4
Thank you. Yes, the Blue Guide is quite helpful. This distributor stores product, and once an order is placed, packages into shipping boxes and ships to customers. They are not involved in returns. Our take is that their services go beyond those of parcel service providers.

We were planning to update our contracts with all economic operators before our first MDR audit in Q42020 to include the new responsibilities under MDR, but thus far this distributor will not, only stating that they are not a distributor under MDR. We would be comfortable if they provided an opinion from the commission, competent authority, etc., but so far nothing. Not even a written statement.
 

dgrainger

Trusted Information Resource
#5
It's going to depend on how the competent authorities interpret the definition in the MDR. Ensuring traceability is an important part of the regulations.

BTW I don't see "add value to the product" in the definition.;)
 
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