Hello Anon RD,
I'd say both you and your Marketing Director have some merited insights. It has been a longstanding medical device precedent in Europe that multiple names can in general appear on the label as long as only one of those names is recognized as the EU MDR Article 2(30) manufacturer. So there can be multiple names, yet only one Article 2(30) manufacturer.
For example, though perhaps not exactly the same as your scenario, Article 16(1)(a) includes a provision where importers and distributors can have their name on the label in addition to a manufacturer's name
as long as the manufacturer is identified as such and is responsible for meeting the requirements of the EU MDR. And if one stretches Article 16(1)'s opening scope, "...
or other natural or legal person..." into point (a), then this multi-name provision clearly would cover your scenario. But that could be viewed by some as too much of a stretch without further concurrence from responsible regulatory authorities. Note that the meaning of, "...
identified as such..." is generally understood to mean use of the EN ISO 15223-1 (as amended) symbol 5.1.1 for 'Manufacturer' with the corresponding operator's name.
Ultimately, I'd recommend a clarification/adjustment in your strategy that would certainly meet the EU MDR legislative requirements. Specifically, if your well-reputed European Maker's name / trade name can be integrated into the
subject device's name / trade name (such as "European Maker Widget", "European Maker brand Widget", etc.,) rather than showing the European Maker as a separate entity/operator, then that would fit nicely into the EU MDR's legislative boundaries. I wonder if you're already doing that? And if not, I wonder if Marketing (and Operations) would consider such an approach in order to meet Marketing's branding goals without compromising the organization's regulatory compliance?
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 27-Jan-2023 05:58
From: Anonymous Member
Subject: Device marked with two manufacturer names
This message was posted by a user wishing to remain anonymous
Hello all,
I've encountered a situation at my current site and would value some thoughts from the wider RA community. We place a device on the EU market with two manufacturers names on the physical item – our UK legal entity name and CE mark as EU MDR Article 2 "manufacturer", and the European maker's trademark name (that is well respected).
The device is a Class I self-declared, non-sterile, instrument and we place it on the EU market in our name with the intention of being the Article 2 "manufacturer", and to comply with the requirements thereof.
We buy the device from a maker in Europe whose trademark name has a stronger reputation than our name has; the European maker leaves their trademark name and location on the device but does not affix any CE mark of their own. The European maker and the UK "manufacturer" are unrelated legal entities.
The European maker has the intellectual rights to the device, we simply buy it from them and, at our request, they put our legal entity name and our CE mark on it. The European maker produces these products for markets other than the medical device industry and we intend that these are sold as medical devices to healthcare professionals under our name.
Hence we have a device with two names on that item. There are two views, internally, on this. The Marketing Director's view, which is the EU MDR does not state that only one "manufacturer" must be named on a device – so his view is we can have our name as Article 2 "manufacturer" as well as the trademark name and location of the European maker. And mine, that only one "manufacturer" should be named on the device as that name has the full responsibility for the product in the EU. Put two names on and who is the manufacturer – us or the (better known) European maker via their trademark?
I would really value and welcome your comments; hope you can help.
And apologies if it's a bit wordy….I wanted to explain it as clearly as possible.
Regards,
RD