This message was posted by a user wishing to remain anonymous
Thanks Richard and Evangelos for your helpful comments.
My doubt was created by the fact that the IVDR requires that the labeling and the declaration of conformity bear the name of the manufacturer and the address of its "registered place of business".
For "registered place of business" it was not clear to me if it intended as the Registered Office. So, this is not correlated?
I just checked in Eudamed, for Actor registration the system simply requires the actor address, no mention to Registered Office or Registered place of business.
Another concern is that, until EUDAMED is fully implemented, I have to continue to register the IVD device in the local authority database (Italian MoH). Here, the address of the registered office is required to register the manufacturer.
Any ideas on how to handle this?
Thanks again for your help.
Original Message:
Sent: 15-Sep-2021 02:21
From: Evangelos Tavandzis
Subject: Manufacturer's address on labeling
Hi Anon
I fully agree with Richard
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Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
Original Message:
Sent: 14-Sep-2021 03:42
From: Richard Vincins
Subject: Manufacturer's address on labeling
Good day Anon,
You can indeed list Company 'X' Address B as the legal manufacturer. Just keep in mind if Address B is listed on the finished device labelling, then they are considered the legal manufacturer, where the primary audit/inspection would occur, and where expected the quality and regulatory information resides. There is no requirement the "Registered Office" of the company needs to be the legal manufacturer, this is really up to the organisation to define relationship between the different facilities. In fact, some of the quality and regulatory items, e.g. Technical Documentation file or DHF, could be located at Address A. Just during an audit/inspection those files and information would need to be readily available - easier if everything is electronic.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 13-Sep-2021 10:11
From: Anonymous Member
Subject: Manufacturer's address on labeling
This message was posted by a user wishing to remain anonymous
Hi all,
I need a clarification on the address of the Legal Manufacturer to be reported on the labeling of an IVD device. I have the following situation:
Company "X" consists of more offices/sites as indicated below:
- Offices with address A: it is the Registered Office of the Company X. It has only the ISO 9001 certification, and the purpose of the certification is about the sales, installation and servicing of IVD devices. It does not cover the design and development of the product in question.
- Production site with address B: where the IVD device in question is designed and manufactured. The site is ISO 13485 certified for "design, development, placing on the market of the IVD device" and has all the procedures that cover the IVDR requirements.
Considering that for the IVDR it is important that the Manufacturer is in possession of an ISO 13485 certification, my idea is to report on the labeling as the name and address of the manufacturer "Company X with Address B".
Is this accepted? Or should the manufacturer's address always be that of the Registered Office (therefore Company X with Address A)? In this case we have a big gap, because the manufacturer is not ISO 14385 certified.
Thank for your suggestions.
Regards