Are all manufacturers required to set up eMDR system?

[ugecha]

Hello, everyone.

I would like to have advice from you.
eMDR becomes effective on August 14, 2015. According to FDA, importers and "manufactures" comply with this new rule. Adverse event reporting must be sent to electronically via Internet after August 14.

http://www.fda.gov/MedicalDevices/D...ectronicMedicalDeviceReporting/UCM2019327.htm

FDA's definition of manufactures is;
Sec. 820.3 Definitions.
(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Here are my questions is;
My company consists of four establishments. One sales office in US (Importer), one head office / design office, (manufacturer), and two factories, (manufacturer), outside of US.
According to the FDA definition, the head office / design office and the factories are considered as "manufacturer". Does this mean that all these "manufacturers" must have eMDR system individually? We, manufacturers, don't have people who can read English documents and understand how computer works and communicate with FDA directly. We always rely on our staff in US. I understand FDA demands eMDR for us but considering risk of our products, our products will never cause death or sever injury. Do we really have to hire new employers just for what is not likely happen?
Or is there any good way to avoid eMDR legally?

I appreciate your help very much.

 

[boyan]

Hi there,

You can't avoid MDR reporting! Do not even think in that direction...
If you are regulated by the FDA I do not get your statement that injury can't happen.
Anyways, who was reporting it before for you? Let them continue doing what they were doing...
Other question is if these 4 establishments are incorporated only one location can do the reporting, in your case US location. You do not need to have 4 eMDR systems if you are operating under the same name (you are the same company). Or you can do this way, wherever you have Quality and Regulatory department (but you should have it where you have manufacturing) they should take the reporting responsibilities.

Best of luck!

 

[Laura Halper]

Hello ugecha,
If I may add to what boyan said. FDA already requires that someone in your company review each product complaint to determine if requires submission of an MDR report, and that someone at your company be designated to submit MDR reports when required. Perhaps your U.S. facility is currently doing this?

Even though you have never had to submit an MDR report in the past, you still have to have a process in place for this. And this includes having a process for submitting electronic MDRs.

I agree with boyan -- you can structure your quality system among your 4 facilities so that the U.S. Importer facility is responsible for reviewing each complaint to determine if MDR-reportable and if so, then submitting the report. It is not necessary to have 4 eMDR individual systems.

Hope this helps,
Laura

 

[ugecha]

Dear boyan,

Thanks for your help. I am glad that we don't need 4 eMDR system. Thank you very much.

 

[ugecha]

Dear Laura Halper

Thanks for your help. I will contact our US office.