Tarek Elneil The MDR reporting the the responsibility of the OEM and the CMO is responsible for the SCAR investigation.

Samantha Pree-Stinson,PMP-C End users are just 1 source for a potential complaint. Make sure that reporting is something clearly defined on paper as far as who owns that responsibility. In addition make sure all employees are given annual training in this area. A potential complaint can come from anywhere, online in an article, conversation etc. So the definition of and how to report are important. In addition, late MDRs are just as bad as not reporting at all. Best to get all of this in order now and find the areas of opportunity to mitigate on your own than an outside body.

Samantha Pree-Stinson,PMP-C You need to make sure that everyone is aware of the definition of a complaint and that they get whatever information thy may come across to

Samantha Pree-Stinson,PMP-C You need to make sure that your glibal training for all employees includes reporting. What is the CFR and what obligations you have to report. Also make sure there is a system to get those complaints to the group on time. Late MDRs are just as bad as lack of or under reporting. An internal audit is a good idea as well so that if you do have any potential for discrepancy in reporting, you can mitigate that now.

Samantha Pree-Stinson,PMP-C The fact that you contract with them still makes your organization liable for making sure that any complaints are evaluated by your MDR group.

Dan O'Leary As a contract manufacturer, you must register and list with FDA. As a type of manufacturer, you must implement the relevant sections of Part 803 on medical device reports. However, if you and your specification developer agree, then you can request an exemption from FDA under 803.19. The draft guidance Medical Device Reporting for Manufacturers, UCM359566, explains the process.

Edward Perry I appreciate the responses. As an ISO13485 organization we have a complaint process that is directly linked to CAPAs unless deemed no investigation needed. I can see a differentiation between "complaint" as per 21 CFR 820.3 (b) where we do not "release for distribution" and communications / complaints per ISO13485. Being that we do not brand our name on the products we contract manufacture, I do not see how any adverse effects would be notified to us but rather the traceability would go to the OEM.

From the guidance:
2.2 Who is considered to be a manufacturer subject to the reporting requirements of the MDR regulation?

A “manufacturer” is any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure [21 CFR 803.3]. The term includes any person who:
Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;
Initiates specifications for devices manufactured by a second party for subsequent distribution by the person initiating the specifications; or
Manufactures components or accessories that are medical devices and that are (1) ready to be used and are intended to be commercially distributed and intended to be used as is, or (2) processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.

Responsibility for complaint handling should be defined in the quality agreement between contract manufacturer OEM. Based on experience in complaint handling, a contract manufacturer taking responsibility is a big risk for OEM. Differences in both parties interpretation of the regulations surrounding complaint handling can lead to compliance risks down the line. Also should the OEM look to change contract manufacturer down the line, the complaint handling aspect of the quality agreement could prove to be problematic.

Based on the CFR you have to implement a MDR process behause you have to follow the complete guideline if you deliver a finished device. But due to the fact that you don't have and get Informationen about the market you still not able to do. My Suggestion: set up a responsibility Matrix and define that the manufacturer will make MDR and you will be fine.

Dan O'Leary There are some side issues here, such as complaints, that I think may be distracting from the original question which I take as, “As a contract manufacturer, do I have an obligation for MDRs?”

Under Part 803, you are a manufacturer and must establish an MDR system. You may not get information that causes you to file an MDR, but that does not affect the requirement to put the system in place. However, you and your specification developer could request an exemption from FDA under 803.19. My prior post cited the draft guidance that explains the situation and how to request an exemption.

If you don’t implement an MDR system or get an exemption, then you will receive a Warning Letter from your next FDA Inspection.

Edward Perry Some excellent information folks. I see a path forward and will review the contract w our customer. As part of our contract review process we already nail down w the customer whether the "item" they want us to make is a device or not. Now to go one step further and work in any ensuing contracts to make the MDR side clear. Thanks again. I like the differences in approach and the open dialog

G M Butcher Follow advice from Dan O'Leary