Hello Anon,
You are right, there may be more legal implications to your question which would need to delve into the regulations themselves to determine who would ultimately be responsible if there was say a corporation type structure of a company with many offices. It is generally understand and accepted by regulatory agencies the name of the company, contact information, and designation on the finished device labelling/information supplied would be considered the Manufacturer/Legal Manufacturer. When you have different entities within an organisation this is probably more a legal question if there were any liability cases which were raised against the company. As an example, I have seen Company A the legal manufacturer on the packaging with name and address identified as Atlanta, Georgia, USA. Company A is a development/manufacturing site of a large corporation Company B. Company B is incorporated and legal presence is in Baltimore, Maryland, USA. From a regulatory perspective, Company A would be responsible. From a legal perspective, maybe Company B? Also have seen many legal manufacturers under one corporation at different sites, but I think the corporate structure would need to be understand to understand if the "Registered Office" would have any responsibility or it might only be related to financial or legal responsibility.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Aug-2021 12:55
From: PASCALE BLANGARIN
Subject: Legal manufacturer address and registered office.
Dear Anonymous,
"Legal Manufacturer means the Person with legal authority to design, manufacture, package and label a product or device before it is placed on the market, regardless of whether these operations are carried out by that Person itself or on its behalf by another Person". Therefore, the address that must appear on the device or the corresponding regulatory documents must be that of the entity ultimately responsible, i.e. the one who assumes legal responsibility for the device. Ask yourself who will be the responsible entity, especially the one who will be insured to meet the requirements of point 15 of article 10 "Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law."
Kind Regards
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PASCALE
France
Original Message:
Sent: 03-Aug-2021 11:48
From: Anonymous Member
Subject: Legal manufacturer address and registered office.
This message was posted by a user wishing to remain anonymous
Hi RAPS community!
I have a question that I think is more legal than regulatory. I hope you can help me.
It is about the Legal Manufacturer qualification, or simply "Manufacturer" if we use the MDR/IVDR definition – i.e. the natural or legal person who manufactures a device and markets that device under its name. The Manufacturer's name and address appear, for example, on the labeling and Declaration of Conformity.
My question is the following: must the address of the Legal Manufacturer necessarily be that one of the Registered Office? (for Registered Office I mean the one that appears in Registrar of Companies registration).
Or the LM address can be different? For example, can it be the address of the site that is indicated as "branch office" in the Registrar of Companies registration?
In fact this "branch site" is responsible for the design, production and placing on the market of the device.
Thanks for your help!