Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have never been in this situation and think we are in the clear, but just wanted to see if anyone had a different opinion.

• We are a medical device manufacturing company based in the USA.
• We collaborated with a medical device accessory manufacturer based on Europe. The Class I accessory is for use with our medical device.
• We have a distributor for our medical device in Europe.

The accessory has some of our IP, so we have an exclusivity clause with the accessory manufacturer. The distributor would like to sell this accessory in Europe.

Because of the exclusivity clause, the distributor must buy the accessory through us. However, we want the accessory manufacturer to drop-ship the accessory straight to the distributor even though financially the order routes through us.

Is this allowed, even though we don't ever see the part in the US? If it never comes to us, we therefore cannot inspect it (although we can't inspect it anyway, since it's a packaged device).

Good day Anon,

Without seeing the exact shipping path and transactions occurring - based on the information provided, yes this is ok.  In fact, shipping products within the European Union is quite ok because it is the Union and free trade.  So if the accessory manufactured by a company in Germany ships to a distributor in Spain, this is not a problem.  It might be more complicated if the accessory was shipped to the US and then back to the EU, but not the case in this scenario.

If the accessory is labelled with your company name, then you are responsible for quality and regulatory aspects.  So even though you might not inspect the device, this is not necessarily a requirement, but the accessory manufacturer could then be considered an external activity or a Contract Manufacturer of a device.  Then it would be managed through the supplier controls.  If the accessory is labelled in their name, then they are responsible.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 18-Apr-2024 11:57
From: Anonymous Member
Subject: Drop Ship Medical Device in Europe, even though we are a US Company

This message was posted by a user wishing to remain anonymous

Hello,

I have never been in this situation and think we are in the clear, but just wanted to see if anyone had a different opinion.

• We are a medical device manufacturing company based in the USA.
• We collaborated with a medical device accessory manufacturer based on Europe. The Class I accessory is for use with our medical device.
• We have a distributor for our medical device in Europe.

The accessory has some of our IP, so we have an exclusivity clause with the accessory manufacturer. The distributor would like to sell this accessory in Europe.

Because of the exclusivity clause, the distributor must buy the accessory through us. However, we want the accessory manufacturer to drop-ship the accessory straight to the distributor even though financially the order routes through us.

Is this allowed, even though we don't ever see the part in the US? If it never comes to us, we therefore cannot inspect it (although we can't inspect it anyway, since it's a packaged device).

First, be clear about the terms 'manufacturer' and 'producer'. The first has legal consequences, the second is of a logistical nature. If you are the legal manufacturer, you need an authorized representative and there will be legal importer (MDR Art. 13) in Europe, regardless of the logistics. Make sure, all that is well organized and is refelcted on the labeling. 

The other problem, regarding quality control, can be tackled via a procedure for product release that you set up together with the producer. You may even audit that supplier. Products will therefore be released on documents, which is fine. Make sure you also enable tracing devices in the distribution chain, preferably by UDI. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands
------------------------------

Original Message:
Sent: 18-Apr-2024 11:57
From: Anonymous Member
Subject: Drop Ship Medical Device in Europe, even though we are a US Company

This message was posted by a user wishing to remain anonymous

Hello,

I have never been in this situation and think we are in the clear, but just wanted to see if anyone had a different opinion.

• We are a medical device manufacturing company based in the USA.
• We collaborated with a medical device accessory manufacturer based on Europe. The Class I accessory is for use with our medical device.
• We have a distributor for our medical device in Europe.

The accessory has some of our IP, so we have an exclusivity clause with the accessory manufacturer. The distributor would like to sell this accessory in Europe.

Because of the exclusivity clause, the distributor must buy the accessory through us. However, we want the accessory manufacturer to drop-ship the accessory straight to the distributor even though financially the order routes through us.

Is this allowed, even though we don't ever see the part in the US? If it never comes to us, we therefore cannot inspect it (although we can't inspect it anyway, since it's a packaged device).