Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer?

[Jango]

Our company markets many medical devices which we source from contract manufacturers which already have certified their products with their own notified bodies. We thus base our applications to our notified bodies based on the technical files of the OEM.

As I understand EU and MHRA regs on own label / virtual manufacturing that since we are placing products on market in our own corporate pack design and brands that therefore we should be considered the legal manufacturer.

However, in our experience, many of our OEM refuse to list us as the manufacturer and seem very surprised at "our request" and will state that they are always the manufacturer and other EU companies don't request to be manufacturer. No one really explains to us their position at least on a legal / regulatory basis.

So I begin to wonder if it is a requirement that we be legal manufacturer or is just an option?

Is this rule on legal manufacturer perhaps not well known or not enforced and thus the OEM's seem unacquainted with it?

Wondering what others have encountered.....

Thanks.

 

[Ronen E]

Re: Who is the legal manufacturer?

Hello Jango, welcome to the Cove

The term “legal manufacturer” (especially “legal”) might be the source of the confusion, and is actually unnecessary here.

The official EU text (currently the MDD, 93/42/EEC) only speaks of “manufacturer”. This term relates to the entity under whose name the device is placed on the EU market, as shown on the labelling (from your description I understand that in your case it’s your org). There’s no need to declare on the labelling who the “legal manufacturer” is, nor who is the actual manufacturer (OEM). The latter is also not forbidden, however.

I don’t exactly understand what‘s the dispute between your org and its suppliers, but there actually shouldn’t be a problem around this issue - the requirements are well known and have changed little over the years, in that respect. The only (related?) change that is relatively recent is the state authorities requirement that OBL / “virtual manufacturers” have their own Technical Files in-house so they can’t rely on the OEM / contract manufacturers’ ones any more.

What I can recommend is that you avoid using the word “manufacturer” (or “manufactured by”) on the labelling as directly qualifying your own org; just state your name and address and that’s it. You can (although you don’t have to) include the OEM’s name and address, qualified by “manufactured by” or similar, as long as you also clarify, either through wording or graphically, that they’re not THE Manufactuer in the rgulatory sense (entity responsible for placing the device on the EU market).

If I missed the whole point of your question please do say so.

Cheers,
Ronen.

 

[paulag]

Re: Who is the legal manufacturer?

Hello Jango,

Maybe some of your suppliers don't manufacture the devices, but already have an OEM themselves. I know from German Notified Bodies that they don't allow OEM-chains.

Besides, with the provisions of the new EU MDR, OEM constellations will not make much sense any more, as you would need access to the full technical documentation,. Not sure if many manufacturer are willing to grant this.

 

[EthanLoh]

Re: Medical Devices sourced from Contract Manufacturers - Who is the legal manufactur

If you buy a medical device from an OEM who already had CE marking and sell it without any modification. You are a distributor. You may need a ISO 13485. Your scope will by "Distribution of XXX".

If you buy a medical device from an OEM who already has CE marking and you put your own brand label, modify the label and IFU. You are a legal manufacturer. Then you will need a Notified Bodies and ISO 13485. Your scope will by "Design and development, Manufacture and Distribution of XXX". This is also known as OEM PLM relationship.

FYI, under the new MDR and IVDR, OEM PLM is no longer allow. E.g. An OEM will never give it full technical file to a PLM for audit purpose.

 

[Sulamistan]

Re: Medical Devices sourced from Contract Manufacturers - Who is the legal manufactur

According EU MDR 2017/745, these are applicable to your scenario.

Article 10, Paragraph 15

Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).

Article 16, Page 29

Cases in which obligations of manufacturers apply to importers, distributors or other persons

1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

(b) Changes the intended purpose of a device already placed on the market or put into service;

(c) Modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.

In your case it really depends on the situation, you can evaluate against the points listed above.

Based on the limited information available, you assume the responsibility of the manufacturer and comply to the regulations accordingly.

 

[ernieto]

Re: Medical Devices sourced from Contract Manufacturers - Who is the legal manufactur

If you buy a medical device from an OEM who already had CE marking and sell it without any modification. You are a distributor. You may need a ISO 13485. Your scope will by "Distribution of XXX".

If you buy a medical device from an OEM who already has CE marking and you put your own brand label, modify the label and IFU. You are a legal manufacturer. Then you will need a Notified Bodies and ISO 13485. Your scope will by "Design and development, Manufacture and Distribution of XXX". This is also known as OEM PLM relationship.

FYI, under the new MDR and IVDR, OEM PLM is no longer allow. E.g. An OEM will never give it full technical file to a PLM for audit purpose.

A company wants to buy our product, they have asked us to support them in becoming legal manufacturer as they will pursue CE mark. Our product is CE marked (IVD). Based on your post, is that scenario allowed? Thank you very much.

 

[supadrai]

Re: Who is the legal manufacturer?

Hello Jango, welcome to the Cove

The term “legal manufacturer” (especially “legal”) might be the source of the confusion, and is actually unnecessary here.

The official EU text (currently the MDD, 93/42/EEC) only speaks of “manufacturer”. This term relates to the entity under whose name the device is placed on the EU market, as shown on the labelling (from your description I understand that in your case it’s your org). There’s no need to declare on the labelling who the “legal manufacturer” is, nor who is the actual manufacturer (OEM). The latter is also not forbidden, however.

I don’t exactly understand what‘s the dispute between your org and its suppliers, but there actually shouldn’t be a problem around this issue - the requirements are well known and have changed little over the years, in that respect. The only (related?) change that is relatively recent is the state authorities requirement that OBL / “virtual manufacturers” have their own Technical Files in-house so they can’t rely on the OEM / contract manufacturers’ ones any more.

What I can recommend is that you avoid using the word “manufacturer” (or “manufactured by”) on the labelling as directly qualifying your own org; just state your name and address and that’s it. You can (although you don’t have to) include the OEM’s name and address, qualified by “manufactured by” or similar, as long as you also clarify, either through wording or graphically, that they’re not THE Manufactuer in the rgulatory sense (entity responsible for placing the device on the EU market).

If I missed the whole point of your question please do say so.

Cheers,
Ronen.

This is completely consistent with our experience as as a "physical" manufacturer. There should be no issues once the semantics are sorted out.

EDIT:

Manufacturers who don't have strong English language skills or an in-depth understanding of the regulations in various jurisdictions (actually, the differences among jurisdictions) often need some hand-holding. Our former JV partner handled all the RA and the adjustment to handling it ourselves upon their departure has been difficult for the factory because they did what they were told without understanding why they were doing it. So taking some time to spell things out simply from the basics may go a long way in helping to develop your supplier.

 

[Shaitan87]

1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

Is this still accurate? I am looking at doing this, selling a product manufactured by someone else, under a new brand name. Being a newbie to selling items that are under this much scrutiny online, I'm having a really hard time finding out exactly what rules I need to follow.

Thanks!

 

[moounir]

Is this still accurate? I am looking at doing this, selling a product manufactured by someone else, under a new brand name. Being a newbie to selling items that are under this much scrutiny online, I'm having a really hard time finding out exactly what rules I need to follow.

Thanks!

This looks like Private Labeling or Own Brand Labeling. With MDR, this kind of model is more difficult as you need to get all the Technical Documentation under your responsibility.

There are some solution that are discussed but no guidance for now. Because I suppose the original manufacturer will not send you the documents so easily.

I hope this will help you.

 

[somashekar]

Our company markets many medical devices which we source from contract manufacturers which already have certified their products with their own notified bodies. We thus base our applications to our notified bodies based on the technical files of the OEM.

As I understand EU and MHRA regs on own label / virtual manufacturing that since we are placing products on market in our own corporate pack design and brands that therefore we should be considered the legal manufacturer.

However, in our experience, many of our OEM refuse to list us as the manufacturer and seem very surprised at "our request" and will state that they are always the manufacturer and other EU companies don't request to be manufacturer. No one really explains to us their position at least on a legal / regulatory basis.

So I begin to wonder if it is a requirement that we be legal manufacturer or is just an option?

Is this rule on legal manufacturer perhaps not well known or not enforced and thus the OEM's seem unacquainted with it?

Wondering what others have encountered.....

Thanks.

When the label of the medical device has your name and address, you are the LM.
When such same device is also labeled by your CM with his name and address, then he is the LM.
Therefore there can be many LM for similar devices based on the label of the device.