How to obtain Own Brand Label (OBL) CE Marking?

NicoleinFlorida

Inactive Registered Visitor
#1
Hello cove,

We are a start-up medical device company located in the U.S. We are considering to introduce a new product as OBL. The OEM of this product has obtained CE mark. I am wondering whether this is feasible and how long it may take us to obtain the CE. This is a Class IIa product.

Comparing with the OBL marking, will it be easier for us to obtain 510k approval? We have two products that have been approved by the FDA.

Thank you for all your valuable inputs.
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
OBL/OEM was never fully recognised in the directive and in recent years the traditional OBL route has been evolving into what is now referred to as virtual manufacturer.

In the past you could request a small amount of documentation from the OEM and submit it along with a technical agreement and the OEM's CE mark only to receive a certificate a month or so later. More recently notified bodies are treating the application as if the OEM doesn't exist. You can still submit their documentation, but the review is thorough and likely to flag issues that were missed by the OEM notified body which will then have to be addressed.

Timescales are heavily dependent on
  • quality of OEM documentation
  • NB leadtime (they are overworked at the moment)
  • device classification
 

RobertvanBoxtel

Involved In Discussions
#3
Based on increased competent authority scrutiny on OBL manufacturers, more and more NB's are moving towards "virtual" manufacturers.
Expectations: Have the complete dossier and the processes in place to maintain it.
Are OEM's willing to provide you with this information?
 

nozzle

Starting to get Involved
#4
I've attended three seminars recently where the notified bodies were leading EU based companies away from virtual manufacturing towards distributed by. There are pros and cons for this but for smaller size businesses it removes the need to hold the full technical file and the unannounced audit fees.
 
#5
We are a EU startup and were able to make all the necessary documentation in about 7to8 months. Getting distributed by is way easier on a regulatory level off course, but a bad idea on a strategic level. When distributing under your own name, the original manufacturer still appears on your label.... For example if you find a good supplier with good quality, you are basically disclosing it to everyone.
 

nozzle

Starting to get Involved
#6
Agreed. Different businesses will approach this in different ways. The big problem for the smaller establishments is the auditing of the technical files. At one seminar I attended a speaker said his company had 50 technical files and the audit time could vary from 2 days to 2 weeks. On one product they ended up with a £15k audit bill for a product they sell £18k worth of.
We've moved to distributed by on some products while remaining VM on others.
 

pkost

Trusted Information Resource
#7
Strategically the business needs to decide how it wants to navigate the regulatory waters, neither distributed or VM is wrong, but the business needs to decide its approach. Fully distributed is the cheapest and easiest, while VM gives the business kudos and benefits that are harder to quantify while coming at an obvious expense. A mix of routes is also feasible and commonly employed

I do not believe that smaller companies will be able to justify or support the VM route from a resource perspective.
 
#8
Hello cove,

We are a start-up medical device company located in the U.S. We are considering to introduce a new product as OBL. The OEM of this product has obtained CE mark. I am wondering whether this is feasible and how long it may take us to obtain the CE. This is a Class IIa product.

Comparing with the OBL marking, will it be easier for us to obtain 510k approval? We have two products that have been approved by the FDA.

Thank you for all your valuable inputs.
Dear Nicolein,

can you give me your contact details, I am also in the same process of starting an OBL and I would like to talk to you about a couple of things if you do not mind.

Regards.
 
#9
We are a EU startup and were able to make all the necessary documentation in about 7to8 months. Getting distributed by is way easier on a regulatory level off course, but a bad idea on a strategic level. When distributing under your own name, the original manufacturer still appears on your label.... For example if you find a good supplier with good quality, you are basically disclosing it to everyone.
Hi Gregski,

may i know your company details to be able to contact with you?

Regards.
 

RobertvanBoxtel

Involved In Discussions
#10
Dear All,

As identified above, NB's are already not accepting anymore the previously "acceptable" OBL constructions. In the EU MDR (and IVDR), you can find in article 10 the requirements that a manufacturer needs to fulfill. The manufacturer as defined in the definition section.
Hence, you can only place products in the EU market if you can demonstrate meeting these requirements, and, amongst others, have followed the applicable conformity assessment route as identified in article 52.

In practice: all manufacturers will need to be able to demonstrate all technical documentation and have the relevant QMS to maintain the technical documentation over the life cycle of the product.
 
Thread starter Similar threads Forum Replies Date
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
M Where to obtain a calibrated DICOM image? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Are we required to obtain a Certificate of Free Sales for export to China? Other Medical Device Regulations World-Wide 6
S ISO 13485:2016 ¶ 8.2.1 - How can we obtain feedback for production activities? ISO 13485:2016 - Medical Device Quality Management Systems 5
G Where to obtain training to program the Keyence Measurement System IM6120 Training - Internal, External, Online and Distance Learning 3
I Shipping Product from Canada to China - Where to obtain the Certificate of Origin? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Eligible to obtain certificate of foreign government (CFG) Other Medical Device Regulations World-Wide 15
A How to obtain Preamble to Quality System Regulation (QSR) ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I California Food & Drug Branch require components manufacturer to obtain license? Various Other Specifications, Standards, and related Requirements 3
I Unable to obtain CSRs from Customer IATF 16949 - Automotive Quality Systems Standard 30
Y Can we obtain ISO 9001 if there is only 1 person that understands the requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Where to obtain ANSI/ASQ Z1.9 C-1 and D-1 tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Are we required to obtain ISO-13485 to act as a Sales Channel for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 3
arios How to Obtain Medical Device Approval in Mexico (Free Webinar November 2011) Other Medical Device Regulations World-Wide 3
D Manhole covers, frames and gratings. Can these products obtain a CE-Mark? CE Marking (Conformité Européene) / CB Scheme 6
K Where to obtain General Concepts of Total Organic Carbon (TOC) testing information? US Food and Drug Administration (FDA) 2
A How do you obtain real Management Commitment Quality Manager and Management Related Issues 18
bio_subbu Basic Primer on how to obtain European CE Marking for a Medical Device EU Medical Device Regulations 0
D How to obtain NOC from DCGI (Drug Controller General of India) for importing drugs Manufacturing and Related Processes 6
P Cost to obtain ISO 13485 Certification/Registration from Start-up ISO 13485:2016 - Medical Device Quality Management Systems 18
T List of regulatory steps to obtain market clearance in different countries ISO 13485:2016 - Medical Device Quality Management Systems 4
A How do we obtain the product requirements for UL Approval? Various Other Specifications, Standards, and related Requirements 6
N How to obtain AS9100 registration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L "Document Controlling" Queries run to obtain information reported to customer Document Control Systems, Procedures, Forms and Templates 7
W ISO17799 - Where to obtain? Other ISO and International Standards and European Regulations 5
K Where I can obtain/view a copy of ISO 14031? Environmental Performance Evaluation Miscellaneous Environmental Standards and EMS Related Discussions 5
5 Honda Supplier Quality Manual - Where to Obtain? Supplier Quality Assurance and other Supplier Issues 12
P Which Organizations can obtain Certification/Registration to ISO/TS 16949:2002? IATF 16949 - Automotive Quality Systems Standard 3
D Professional Liability Insurance - Have been asked by a registrar to obtain! Consultants and Consulting 16
A Distance Learning where I would be able to obtain a 4 year degree in Quality? Training - Internal, External, Online and Distance Learning 7
M Daimler Chrysler SQM (Supplier Quality Manual) - Where to obtain a copy Quality Management System (QMS) Manuals 9
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
J Create your own symbol? Other Medical Device Related Standards 7
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
C Can You Internally Audit a Process You Own? Internal Auditing 25
S Calibrating our own equipment, can we? Micrometers to calibrate vernier calipers General Measurement Device and Calibration Topics 13
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
U Own Procedure was not effectively implemented Problem Solving, Root Cause Fault and Failure Analysis 3
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 144
C Can we be our own EU authorised representative? EU Medical Device Regulations 31
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
A 3D Printing concept in airline to manufacture its own aircraft cabin parts EASA and JAA Aviation Standards and Requirements 3
F AEMPS (Spain) Registration - Medical Devices - We do not own the products we make EU Medical Device Regulations 2

Similar threads

Top Bottom