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Components to a finished medical device, MDR requirements

Rosco

Registered
#1
Hello!
I'm trying to better understand the MDR requirements in regards to components for a finished medical device, that are shipped to both our Companies service team in the field, and also to authorized BioMeds at accounts. Occasionally these components, in this case an IV Pole, will break in transit. My concern is if an IV Pole were to break, and a service technician were to cut their hand, would I be obligated to file a MDR to capture the incident. Especially if the recipient of the component is a BioMed and not an employee of our company, in other words the component was no longer in our companies control. The IV Pole is not sold as a stand alone device. It can only be used with the finished good, and is only shipped to a tech/customer for repair. I'm unclear if this would fall under the realm of accessories.
Any thoughts would be greatly appreciated.
 
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yodon

Staff member
Super Moderator
#2
Not an expert here but maybe it'll kickstart the discussion.

I don't think whether it's an accessory or not has any bearing.

I kept trying to convince myself that it wouldn't be reportable but if the event is considered a serious injury then it seems it would be since:
  • you might consider the injury a result of: ... (3) Improper or inadequate design,
  • the 'malfunction' may recur
I tend to take a more conservative approach to reporting. You'd definitely be wise to get regulatory expertise to weigh in.

You mention that it was out of your control; however you also say that it could be a result of damage in shipping. Sounds like your packaging (what I'm considering inadequate design above) may not adequately protect the component in shipping (and especially if this is recurring). Has there been any thought given to improving the packaging?
 
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