I'm interested in knowing how you receive complaints on these optional devices, if you don't manufacturer or distribute them. Are you listed as the manufacturer/contact on the packaging?
To answer your question - Does your IFU state use of this optional device? if it does- that ties it to the safety & performance of your own device and you must first report to the manufacturer know even though you don't distribute it.
As per 21 CFR 803, "
If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files."
Based on your complaint handling procedures, if the failure of the optional device contributed to failure/malfunction of your own device, you must also report to regulatory body and determine the need for MDR. Your investigations could be dependent on the investigations of the 510k/CE cert owner of the optional device.
If the device was used within its service life but now has passed it, the owner of the 510k/CE cert would still have to investigate & if needed report. Retrospective reporting is not uncommon.
------------------------------
Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
------------------------------
Original Message:
Sent: 30-May-2018 02:26
From: Rashmi Pillay
Subject: Complaints -accessory
Hi,
If there's been a complaint because of failure of an optional accessory ( not manufactured or distributed by us) used on our systems, who is responsible for the complaint handling ? If its determined as an adverse event who has the responsibility of reporting ? If the device has crossed its service life , then do it's complaints need to be evaluated by the manufacturer ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
.............................................................................
One Powerful Vision.
Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.