Retailer obligations as distributor


Starting to get Involved
Hi everyone.

As I understand it under both MDR and IVDR a "distributor" is defined as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service."

On that basis does a retailer in the UK have to comply with the distributor requirements? e.g. if a product is MANUFACTURED in China, and our UK company is the IMPORTER and DISTRIBUTOR and we sell the product to a UK retailer, are they also considered a DISTRIBUTOR? I cannot find any reference to retailers other than in relation to the UDI. We and many other companies are in the same position with home use MDs, so I am surprised MDCG etc haven't published anything. What am I missing?

Thank you.


Quite Involved in Discussions
What am I missing?
I think you are missing that that UK has left the EU :)
Therefore, MDR/IVDR do not apply. So no, a UK distributor does not need to comply with the MDR requirements.

You need to review the UK regulations to confirm what you need to do for distributing product there. AFAIK the UK only recognizes the manufacturer and the UK Responsible Person ("authorized rep"), I do not think the distributors have defined responsibilities for UK.
Register medical devices to place on the market


Starting to get Involved
I understand your point. BUT we sell into GB & NI so with the NIP we still need to comply. Plus the regs were all written pre-Brexit so that doesn’t explain the lack of references to retail. I am starting to think that either nobody gave retail a thought OR obligations terminate with the last link in the chain ie the distributor.

Appreciate it if anyone else has anything to add.

Ronen E

Problem Solver
Under the MDR a Distributor "makes a device available on the market, up until the point of putting into service".

"The point of putting into service" = where the device is used (normally refers to capital equipment that requires installation, e.g. an MRI machine). So this doesn't exclude a retailer (who, by definition, sells to the end user, or in other words - to someone who doesn't sell or transfer any further). Putting into Service always happens AFTER the act of transfer (so in essence AFTER the supply) and is not - IMO - in the scope of, or relevant to, the last transaction in the supply chain. Putting into Service derogates from obligations normally applicable when Placing on the Market, but that's irrelevant for the current discussion.

‘Making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

A retailer "supplies a device for consumption or use", so they Make Available on the Market. Hence, a retailer is a Distributor under the MDR. The reason it's not discussed in guidance is that it's a straightforward result of the definitions.

In the current state of affairs retailers based in NI need to address the Distributor obligations under the MDR.
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