Repacking of Service Parts and Components for Medical Devices

[DeGeuk]

Hi Guys,
I'm working for a 3GPL warehouse company (Europe) with medical device companies as customers. (This means we don?t own the parts, we just store and handle them)
One of our customers ships parts and components to us. We receive these in bulk. They ask us to repack these parts individually and label them so we can send these spare parts for service to their customers. (We don't do service, we just send the parts). Parts are shipped all over the world.

I having a discussion at the moment regarding FDA 21 CFR 820 regulations. If I read the QSR properly, this action (Repack and labeling) makes us part of the manufacturing process.

Am I wrong to think/ask that we:
1. Should register as manufacturer?
2. Ask our customer to give is packing instructions and specifications (for the boxes and bags) so we comply with the QSR?
3. Don?t need to build a Device Master Record file for each part, because this information is available at our customer. (and the repack instructions are more than enough)?
The reason why I ask is that I get conflicting answers from colleague Quality Managers and my(our) knowledge of FDA regulation is limited
Thanks in advance for the advice

 

[Ronen E]

Hello and welcome to the Cove

In repacking and labeling components (not finished devices) you will become a component supplier to a medical devices manufacturer. IMO you will not qualify as a Contract Manufacturer, provided that these components can't / are unlikely to be used as medical devices on their own.

AFAIK component suppliers don't need to register and 21 CFR 820 does not directly apply. It's the responsibility of your client to ensure overall compliance with part 820 (assuming those components are labeled with their name, not yours), and as such they may pose some requirements on you, contractually; however, it is not your regulatory responsibility to study part 820 and decide what you need to do.

Either way, it would be very wise to ask them for detailed and complete specifications and work instructions regarding the work at hand.

Cheers,
Ronen.