Different Label Address Required for EU?

B

BDM35

#1
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!
 
Elsmar Forum Sponsor
#3
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

Trusted Information Resource
#4
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
 
M

MIREGMGR

#5
"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.
 
K

KaCey1

#6
Is there a single table / document available outlining the similarities / differences between the FDA and EU requirements?

Thanks!
 
M

MIREGMGR

#7
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

Problem Solver
Staff member
Moderator
#8
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.
 
Thread starter Similar threads Forum Replies Date
E Expiration Date on Label for different Countries (Short Shelf Life Product) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Mobile Equipment - Six label printer to be used in different areas Qualification and Validation (including 21 CFR Part 11) 4
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
T Different Authorized Representative and distributors in Saudi Arabia Other Medical Device Regulations World-Wide 0
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Yield Plot for different groupings Using Minitab Software 3
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 1
F How do you add accuracies for tools with different measurement devices? General Measurement Device and Calibration Topics 1
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
A Statistical Analysis - Check if these organisms at different concentrations affect the growth of wheat seedlings Using Minitab Software 4
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Identical Sales Package in Different Countries Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
E Different requirements for Class II and Class III Medical Devices Other ISO and International Standards and European Regulations 5
C Subsidiaries; same/different Quality Policies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Controlling documents in two different Applications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
H IFU in different language other than English EU Medical Device Regulations 5
J Ethicon Suture - Why Ethicon specs are different internationally Other Medical Device and Orthopedic Related Topics 0
A Torque Value for Different types of Fasteners (Socket Head, Button Head, CSK) Manufacturing and Related Processes 2
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
E Different types of Actions? CARs, OFIs or N/A ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J DoE (Design of Experiments) - Multiple responses with different factors Using Minitab Software 2
smryan ISO 9001:2015 8.6 & 8.5.1.h) - Redundant or different? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Additional Controls for processing the raw data on different computers (processing system) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
A PFMEA severity score different applications FMEA and Control Plans 11
xfngrs How similar or different are IATF 16949 Vs. ISO 13485 IATF 16949 - Automotive Quality Systems Standard 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
B IATF 16949 - Different Registrars for remote and manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 2
W Transport validation to different climate zones ISO 13485:2016 - Medical Device Quality Management Systems 13
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Is it ok to provide a different language upon request? EU Medical Device Regulations 25
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
D Design Transfer between two companies with different QMS CE Marking (Conformité Européene) / CB Scheme 3
P Any official doc/spec on different types of Yield calculation? Manufacturing and Related Processes 0
R Medical devices certified by different notified bodies EU Medical Device Regulations 6
V Software as control or protection will lead to different Software Safety Class? IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
M I have 3 different factors - DOE help Statistical Analysis Tools, Techniques and SPC 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
T QMS/MDD scope - Two companies located in different places work together Human Factors and Ergonomics in Engineering 10
A Why I get a different kind of regression equation when I do the same data in a differ Using Minitab Software 7
W Can 2 different sites under different Quality System have a common management review? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Indications for Use - Is it possible to have a different indication for use EU Medical Device Regulations 1
Similar threads


















































Top Bottom