Different Label Address Required for EU?

[BDM35]

Hello,

I was wondering if someone can help me answer my question regarding whether or not our label address needs to be changed for ISO purposes?

We currently have registered places of business in the EU, however, neither site has any regulatory personnel based at either one. I was informed without a person(s) who are sufficiently familiar with compliance regulations, we would have to obtain an authorised representative.

If I have to obtain an authorised rep, would I now have to changed the information on the label that is exported to the EU to reflect the authorised rep?

As it stands, the label reads,

Manufactured for ______
address
contact number

That would now have to come off the label and be replaced with the authorised rep(s) information?

I appreciate any insight you can give! Thanks!

 

[Ronen E]

http://elsmar.com/Forums/showpost.php?p=548213&postcount=14

 

[lynchoid]

Hello,

I was wondering if someone can help me answer my question regarding whether or not our label address needs to be changed for ISO purposes?

We currently have registered places of business in the EU, however, neither site has any regulatory personnel based at either one. I was informed without a person(s) who are sufficiently familiar with compliance regulations, we would have to obtain an authorised representative.

If I have to obtain an authorised rep, would I now have to changed the information on the label that is exported to the EU to reflect the authorised rep?

As it stands, the label reads,

Manufactured for ______
address
contact number

That would now have to come off the label and be replaced with the authorised rep(s) information?

I appreciate any insight you can give! Thanks!

Actually, if you sell medical devices into the EU, you absolutely do have to name an authorised rep, but not because you have no compliance people at your offices there. The Competent Authorities expect you to have a representative on European soil that they can communicate with in the event of an emergency recall.

"

For MD and IVD, the label or outer packaging or instructions for use shall contain the
name and the address of the authorised representative where the manufacturer does
not have a registered place of business in the Community (MDD Annex I Section
13.3(a); IVDD Annex I Section 8.4 (a)). For AIMD this information shall be affixed on
the sales packaging (AIMDD Annex 1 Section 14.2).
The purpose of this compulsory designation is, as expressed in Recital 16 (MDD),
Recital 14 (Directive 2007/47/EC), and Recital 29 (IVDD), that the authorities must be
able to contact a person responsible for placing the device on the market and
established in the Community, particularly in cases of emergency.
The definition of an authorised representative in the Medical Devices Directives, is:​

“authorised representative” means any natural or legal person established in the
Community who, explicitly designated by the manufacturer, acts and may be
addressed by authorities and bodies in the Community instead of the manufacturer
with regard to the latter’s obligations under this directive;”​

The definition of an authorised representative in Regulation 765/2008/EC is as
follows:​

“authorised representative” shall mean any natural or legal person established within
the Community who has received a written mandate from a manufacturer to act on
his behalf in relation to specified tasks with regard to the latter's obligations under the
relevant Community legislation;​

The authorised representative has certain obligations as defined by the relevant
Directives, such as:​

4/17​

- informing the competent authorities of his registered place of business (MDD: class
I, procedure packs and custom made devices; AIMDD: custom made devices; IVDD),
and of the devices and certificates (IVDD);
- keeping certain information at the disposal of the national authorities, such as
declarations of conformity and technical documentation (AIMDD Annex II 6.1; MDD
Annex II 6.1, Annex III Section 7.3, Annex IV Section 7, Annex V Section 5.1, Annex
VI Section 5.1, Annex VII Section 2; IVDD Arts 9(7) and 10(3)).

You do not replace your address with the Auth Rep, you must display both. Either of your offices in Europe should be able to be designated so.​

 

[pkost]

The statement "manufactured for" confuses me and may not be compliant....who is the manufacturer as defined by the directive?

If it is the person stated as "manufactured for" then it is incorrect and confusing as they are the manufacturer and it is not manufactured for them

If it is the person who does the manufacturing and not the person it is manufactured for, then it is non compliant because it doesn't state who the manufacturer actually is!

All a bit confusing!!

Essentially just state:
manufacturer (or use the EN980 symbol): Acme Inc

 

[MIREGMGR]

"Manufactured for" (or alternately, "distributed by") are FDA-unique labeling language, utilized in a "private labeled" context. Private labeled devices are allowed per this exception to the general labeling rules to be labeled with the name of their distributor instead of the actual responsible manufacturer.

There is no exactly-equivalent labeling condition in the EU, therefore a device label that utilizes this approach for the US market cannot be used in EU without having additional content to address the different labeling approach required in EU.

 

[KaCey1]

Is there a single table / document available outlining the similarities / differences between the FDA and EU requirements?

Thanks!

 

[MIREGMGR]

Not that I'm aware of.

***

On a separate note: looking back at the thread, it should have been noted more clearly that the original poster's company is not the responsible manufacturer of the device in question. Their role rather is that of distributor. It was suggested here that they would have to have an EU Rep to bring the product to the EU market. That pathway would only work in a complicated scenario in which they--the USA distributor--take on the responsible Manufacturer role (or, using the terminology of MHRA Bulletin 19 or ZLG/EK-Med guidance 3.9 B 16, "Private Label Manufacturer"...note this has an opposite meaning to the FDA-use of the same words) in the EU, while the responsible Manufacturer for USA takes on a contract manufacturing (or "OEM Manufacturer") role in the EU.

That's not an impossible degree of complexity--my employer does it in reverse for a line of products we import from Austria--but it does introduce some extra issues. I'm expecting the UDI implications to be challenging, for one.

 

[Ronen E]

Not that I'm aware of.

***

On a separate note: looking back at the thread, it should have been noted more clearly that the original poster's company is not the responsible manufacturer of the device in question. Their role rather is that of distributor. It was suggested here that they would have to have an EU Rep to bring the product to the EU market. That pathway would only work in a complicated scenario in which they--the USA distributor--take on the responsible Manufacturer role (or, using the terminology of MHRA Bulletin 19 or ZLG/EK-Med guidance 3.9 B 16, "Private Label Manufacturer"...note this has an opposite meaning to the FDA-use of the same words) in the EU, while the responsible Manufacturer for USA takes on a contract manufacturing (or "OEM Manufacturer") role in the EU.

That's not an impossible degree of complexity--my employer does it in reverse for a line of products we import from Austria--but it does introduce some extra issues. I'm expecting the UDI implications to be challenging, for one.

Please note that the OP was about EC representation. If the entity placing the device on the EC market has a registered place of business in the EC, the device is treated as if it was made in the EC. The fact that that entity is not actually creating that device, or that the actual maker is located outside the EC, matters not in the EC rep context.

The issue you've highlighted has to do with proper CE marking. If the entity placing the device on the EC market can't duly affix a CE mark (for any reason), they're not allowed to place the device on the EC market regardless of any geographical or registration aspects. If another entity already has EC clearance for the same device, they might be able to tap onto that through the OBL CE marking route; otherwise they would probably need to work with the OEM to obtain clearance under their own name.

Cheers,
Ronen.