OBL (Own Brand Labeling) - Full Quality to Production Quality

sriramsl

Involved In Discussions
#1
Dear Experts
Need advise again.
Currently we have CE marking for a Medical Device procured from a OEM under OBL route with a product model name 'XXX'. This is obtained under Full Quality Assurance - Annexure II. (Here the complete TF of the OEM is submitted from Design to manufacture - we only issue Labels and IFU with our Model name XXX)
Now we want to do 'manufacturing' of the same product with an agreement with the OEM that they supply us all the components. The final product will be exactly same as product 'XXX' in every aspect. We do not want to change the Model name of the product.
The questions are:
1. Do we have to build the TF again and get fresh CE marking approval by NB or
2. Do we have to mention only as significant change of 'manufacture' moved from OEM to our factory
3. Under which Annexure do we have to apply - Annex II Full Quality or Annex V - Production Quality?
 
Elsmar Forum Sponsor

sriramsl

Involved In Discussions
#3
Re: OBL - Full Quality to Production Quality

Thanks Remus for the quick reply.

How come the answer can be Yes for both the questions 1 and 2. If I can file Significant change of Manufacture, then I dont have to prepare the full TF again and submit isn't it. Only documents related to the manufacture should suffice. Am I right?

Regards
Sriram
 

Remus

Involved In Discussions
#4
You have to prepare full technical documentation, however you can use your OEM's documentation. After that you need to manufacuture some products, prepare your process validations, quality and manufacuturing documentations. Then, your notified body will audit your manufacturing area, and documentation.

In my opinion prepare everything to your survalliance audit, dont pay extra audit fee.

PS: Talk with your notified body, because every NB have different aproach somehow.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I second the recommendation to talk with the current NB because the current situation with OBL certification (in general) is unclear at best. The EU is generally moving away from what used to be referred to as OBL CE marking (certification of the OBL based on the OEM clearance).

My guess is that they will instruct you to prepare everything fresh and then get certified in your own right. The fact that your design and components will come from a certified manufacturer (the OEM) can help but it won't be a huge shortcut like OBL arrangements used to. You will most likely need the support of the OEM in terms of existing documentation.

The annex you need to apply is a function of device classification. Annex II is a catch-all route but it might be an overkill in your case (or not, depends on the class).

Good luck,
Ronen.
 

sreenu927

Quite Involved in Discussions
#6
I agree to Ronen that EU is moving away from OBL. Recently our Notified Body told "No" to OBL. Either you need to take the legal responsibility or act as a distributor.

Regards,
Sreenu
 
Thread starter Similar threads Forum Replies Date
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18
L ISO 13485 and OBL (Own Brand Label) Agreement EU Medical Device Regulations 20
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
P OBL (Own Brand Label) - Annex III ? EC Type Examination EU Medical Device Regulations 2
S Piggybacking on OEM to become OBL (Own Brand Label) CE Marking (Conformité Européene) / CB Scheme 5
R Technical File - Own Brand Labeling (OBL) Requirements EU Medical Device Regulations 13
somashekar Own Brand Labelling (OBL) Agreement ISO 13485:2016 - Medical Device Quality Management Systems 4
E Original Brand Labeler (OBL) in China China Medical Device Regulations 2
S OBL under new MDR EU Medical Device Regulations 2
B Virtual Manufacturer / OBL ISO Requirements Other ISO and International Standards and European Regulations 3
M Audit Mandays for OBL/Virtual Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
M OEM vs OBL Classification in the CE Certification EU Medical Device Regulations 5
K Does OEM/OBL-Relationship need to involve an EU Authorized Representative? EU Medical Device Regulations 11
S OBL CE Marked Medical Device Labels EU Medical Device Regulations 5
P Medical Device OEM, OBL and Private Labeling Questions EU Medical Device Regulations 5
C Termination of Technical Agreements with OEM (OBL) ISO 13485:2016 - Medical Device Quality Management Systems 1
A Industrial OBL Practices EU Medical Device Regulations 5
somashekar Is OBL CE Marking route for Medical Devices being Reconsidered? EU Medical Device Regulations 4
R NB ruling on OBL Submission Question EU Medical Device Regulations 3
C Is there and OBL and OEM Contract Template? EU Medical Device Regulations 16
B Listing both OEM which is owned by OBL on a CE Mark Certificate CE Marking (Conformité Européene) / CB Scheme 4
P OBL / PLM within the US Medical Device Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Distribution of OBL Product - Does this constitute manufacturing? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
Y Analysis of Data Procedure: Requirements for OBL (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 2
F Medical Devices in EU - OEM or OBL? EU Medical Device Regulations 1
B OEM/OBL Quality Agreement vs. Technical Agreement ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical Devices and Licensing of Trademark to an OBL in UK EU Medical Device Regulations 6
pbojsen OEM / OBL "Private labeler" agreement template? EU Medical Device Regulations 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
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
B Submit a Special 510(k) or "Documentation by our own" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7

Similar threads

Top Bottom