For the ISO 15223-1 / EN ISO 15223-1 (as applicable and as amended) filled-in factory symbol 5.1.1 (as distinguished from the open factory symbols 5.1.3 and 5.1.11), the meaning/role of the entity named next to symbol 5.1.1 depends on the particular jurisdiction's definition of "manufacturer" and/or "manufacture". These terms aren't universally defined; instead, there can be important differences depending on the jurisdiction.
For example regarding Europe's Union, the "manufacturer" is the economic operator that is ultimately / legally accountable and responsible for ensuring conformity of the subject device with the EU MDR. And unless otherwise indicated on the label, the EU MDR establishes that this "manufacturer" is the person under whose name or trademark the device is marketed (i.e., this is the person named on the label). This remains the case even though the entity on the label may not actually do any device manufacturing/fabrication, and even in cases such as a wholesale "own-brander" / private label distributor who doesn't actually own/control the device specifications.
Canada's approach is similar to Europe's.
In contrast, the United States (U.S.) has a different approach. Specifically, if symbol 5.1.1 is used on a U.S. medical device label to identify the "manufacturer", then, unless otherwise indicated using a Part 801 disclaimer like "Manufactured for", "Distributed by", etc., the U.S. Federal Register states that the FDA will generally conclude that the named entity is the person/location that actually (e.g., physically) fabricates the device. In other words, for U.S. device labels, the named party isn't necessarily considered to be the "legal manufacturer" (e.g., ultimately responsible for overall device quality) simply by virtue of being named on the label. This is a stark difference compared to other jurisdictions like Europe and Canada.
Here's further explanation of this U.S. nuance for those interested: For the unique purposes and context of medical device labels, the U.S. applies more plain-language interpretations to "manufacturer" and "manufacture" rather than being focused on overall legal/virtual responsibility. More specifically, regarding identification of the "manufacturer" on the medical device label, the U.S. FDA takes a stance that is more concerned about assuring that the label shall either a) identify where the device is actually fabricated and by whom, or else b) identify that the person/site identified on the label is not actually the person/site doing the actual fabrication. In other words, for U.S. labels, the main focus is about identifying the person/site doing the actual fabrication (or the existence of such person) rather than on identifying who is legally responsible for overall quality. This seems to be driven by FDA's concerns regarding good manufacturing practices. Again, this interpretation is limited to the context of labels, and is supported by longstanding U.S. FDA interpretation and precedent established repeatedly in the U.S. Federal Register explaining FDA's interpretation of "manufacturer" for the context of labels and 21 CFR Part 801.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 30-Aug-2022 05:41
From: Anonymous Member
Subject: Manufacturer definition beside the chimney symbol on device label
This message was posted by a user wishing to remain anonymous
Hi, experts,
I have a question about the manufacturer be listed beside the chimney symbol on device label.
If only allowed to list legal manufacturer? Or physical manufacturing site may be listed as well?
The reference of labeling is ISO 15223 or else?
Thank you for help!