Does OEM/OBL-Relationship need to involve an EU Authorized Representative?

K

Kh_Nadja

#1
Hello everyone!

Company I work for is a medical device manufacturer established in the EU (let's call it "Company A"). We are going to enter into OEM-collaboration with a company located outside the EU ("Company B"): the idea is that they will obtain a CE-mark and start producing a device that we, Company A, will be selling in Europe under our name. So, in terms of MDD we will act as a legal manufacturer of this product.

This product makes sense only if we, Company A, sell it (it is an accessory to another device that we own), the original manufacturer has no use of it otherwise.

Company B is already selling a range of other products in the EU and has an authorized representative on the European market.

The question is - does their authorized rep need to co-sign the declaration of conformity for this item, even if they will not have to perform any duties on the EU market? This seems a bit unnecessary, because no one except Notified Body and Competent Authorities will ever know that Company B produced it, as we are the legal manufacturer and take care of the regulatory part ourselves.

Could anyone please help me with this? :thanx:
 
Elsmar Forum Sponsor

somashekar

Leader
Admin
#2
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Short answer is yes. The regulatory is not concerned with how you do business.
Company B has the CE mark for that device, and they are out of the EU. The EU AR is involved.
 

Ronen E

Problem Solver
Moderator
#3
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Company I work for is a medical device manufacturer established in the EU (let's call it "Company A"). We are going to enter into OEM-collaboration with a company located outside the EU ("Company B"): the idea is that they will obtain a CE-mark and start producing a device that we, Company A, will be selling in Europe under our name. So, in terms of MDD we will act as a legal manufacturer of this product.

This product makes sense only if we, Company A, sell it (it is an accessory to another device that we own), the original manufacturer has no use of it otherwise.

Company B is already selling a range of other products in the EU and has an authorized representative on the European market.

The question is - does their authorized rep need to co-sign the declaration of conformity for this item, even if they will not have to perform any duties on the EU market? This seems a bit unnecessary, because no one except Notified Body and Competent Authorities will ever know that Company B produced it, as we are the legal manufacturer and take care of the regulatory part ourselves.
As the legal manufacturer you need an EC certificate, regardless of whether the actual manufacturer (OEM) has one. Since you are located inside the EU you don't need an Authorised Rep. The OEM (company B) AR is irrelevant.

As much as I understand the "old" OBL CE marking arrangement is practically discontinued and you will most likely be unable to benefit from it. You will need to obtain the EC certificate just as if you were the actual manufacturer. Since you aren't, you will need the full support of the OEM.

Cheers,
Ronen.
 
K

Kh_Nadja

#4
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thank you Ronen for your reply!

Could you please elaborate in more detail about the current practice around OBL arrangement and what it means that it got discontinued?

I read about the trend of tightening up the controls over OBLs after PIP-implant scandal, but I thought the ultimate result was that OBLs now are required to keep full technical file (instead of a summary, as it was before), and that the review of the full file was the ultimate measure, which normally would not be required. But are the things even worse?
 

fialor

Involved In Discussions
#5
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thank you Ronen for your reply!

Could you please elaborate in more detail about the current practice around OBL arrangement and what it means that it got discontinued?

I read about the trend of tightening up the controls over OBLs after PIP-implant scandal, but I thought the ultimate result was that OBLs now are required to keep full technical file (instead of a summary, as it was before), and that the review of the full file was the ultimate measure, which normally would not be required. But are the things even worse?
Kh_Nadja
Short answer:
They do not need to as they should not be CE marking unless they have a commercial reason.
You will hold all the documentation because OBL as we knew it is dead.
Long Answer:
The "old" OBL structure allowed a manufacturer to essentially re-label a product already on the market as its own, effectively "piggy backing" off of the original manufacturer’s CE mark.
The trend now, and it will be more tightly controlled with the new MDR, is that the OBL route of "piggy backing" no longer apply. Your NB will require that as the Legal Manufacturer you hold all the required technical documentation or have access to it (my notified body interpreted the later to mean onsite when we ask for it).
Whereas the "old" trend was to hold a top-level STED and refer to the CE mark that the original manufacturer held, plus there was no onsite requirement for the OBL.
With the Legal Manufacturer of the re-labelled product needing to hold all the technical documentation, it negates the need for the OEM to CE mark their devices, unless of course they have a commercial reason to.
That is not say your OEM cannot CE mark their device; they can and it might make it easier for you to access the required documentation for your technical file.
If they do want to CE mark the device, they will need the EU AR to be responsible as they will be selling you (placing on the market) a finished medical device and not a component.
For clarity, the MDD does not require the EU AR for a commercial contract for a product they do not place on the common market.
 

Ronen E

Problem Solver
Moderator
#6
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

as they will be selling you (placing on the market) a finished medical device and not a component.
I'm not sure that this is correct. Company A will be the EU importer in that scenario, and sale to the importer is not (as far as I understand the term) considered Placing on the Market. Rather, it's the first sale made in the EU, ie by the importer. This is how I read the Blue Guide, but I might be wrong.
 
Last edited:

fialor

Involved In Discussions
#7
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

I'm not sure that this is correct. Company A will be the EU importer in that sacenario, and sale to the importer is not (as far as I understand the term) considered Placing on the Market. Rather, it's the first sale made in the EU, ie by the importer. This is how I read the Blue Guide, but I might be wrong.
Thanks Ronen E.
The Blue Guide states
"— A product is placed on the market when it is made available for the first time on the Union market.
— Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market."

In my experience unless the sale to Company A happens outstide of the EU, it will be an EU sale and therefore the placing of the market definition applies.

I am happy to hear others' experiences.
 

Ronen E

Problem Solver
Moderator
#8
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Thanks Ronen E.
The Blue Guide states
"— A product is placed on the market when it is made available for the first time on the Union market.
— Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market."

In my experience unless the sale to Company A happens outstide of the EU, it will be an EU sale and therefore the placing of the market definition applies.

I am happy to hear others' experiences.
If the seller is based outside the EU and the buyer inside, does the sale happen inside or outside the EU?

I vaguely remember that there are some examples in the Blue Guide and I think that that was where my opinion originated.
 

L_O_B

Involved In Discussions
#9
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

The Blue Guide says that only manufacturers and importers may place products on the market. Every subsequent distribution is called making available. Therefore the delivery of a device from a third-country manufacturer to a legal or natural person inside the EU is not yet deemed to be placing on the market.
The legal or natural person receiving the device first is now the importer and may place the device on the market.
As far as I understand it
 
K

Kh_Nadja

#10
Re: Does OEM/OBL-relationship need to involve an EU authorized rep?

Just found a European Commission guidance regarding the interpretation of the term "placing on the market" (attach it to the post in case anyone could also find it useful). It says:

"Under certain circumstances, however, the placing on the market of an imported medical device does not coincide with its release for free circulation, namely in cases where that product has not yet been transferred from the stage of manufacture to the distribution stage. For example, this would be the case ...
- where the product is transferred to a manufacturer’s (or the authorised representative's) warehouse as long as the product is not yet made available on the market. This includes the case where the goods are stored in the warehouse of a European manufacturer who has the product designed and manufactured outside the EU and markets it under his own name or trademark in Europe."


So, as Company A is a legal manufacturer, it is this company who places the device on the market, so I would guess that the EAR should not be involved. :cfingers:
 

Attachments

Thread starter Similar threads Forum Replies Date
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A When purchasing gauges does the OEM need to be accredited to 17025? ISO 17025 related Discussions 8
S What does OEM exactly mean? What does "equipment" include? IATF 16949 - Automotive Quality Systems Standard 2
J Definition OEM & PPAP - Definitions - What does OEM & PPAP stand for & what do they mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 15
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
P Does cybersecurity apply to my product? EU Medical Device Regulations 5
Q Does a gage used for a visual verification need to be calibrated? Manufacturing and Related Processes 7
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
B Does TUS require load thermocouples? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
S Why does GAGEpack drop the temperature and humidity readings out of the verification event card? Quality Assurance and Compliance Software Tools and Solutions 0
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
G When does containment event not require 100% sort? Nonconformance and Corrective Action 5
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 5
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
T What does VW mean by annual requalification? Customer and Company Specific Requirements 4
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 6
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1

Similar threads

Top Bottom