Own Brand Labelling and Distributors - Self Test IVD's


I would appreciate some help with the following scenario.

We (UK Company B) purchase Self test IVD's for home use (pregnancy tests) from OEM (China Company A) as OBL with our name.

We have ISO 13485 and Notified body approval as an OBL.

We have a request from UK Company C (UK retailer) to provide them the same product with company C trademark on front of pack and company C pack design with Company C noted as distributor and company B as manufacturer.

Our notified body has said this can't be done. Notified body and all the regulations seem to say that Company C becomes the manufacturer and has to fulfill all the required manufacturers quality system requirements as well as apply to their own notified body for approval of the products.

Every UK retailer as well as many European retailers has their own brand of pregnancy test branded as their product but with distributed by instead of themselves as the manufacturer. It has been this way for many years.

How is this achieved or has it all changed with the adoption of the 2013 & 2016 rules?
Elsmar Forum Sponsor


Trusted Information Resource
It is possible for your brand to act as declared manufacturer on pack, while displaying another brand. As you said - many other companies do this.

You need to understand why your notified body has said no, perhaps they are misunderstanding your requirements.

key things required for this:
Technical agreement to identify obligations
IP agreement - license for you to use their brand and that they are the exclusive purchasor


From the viewpoint of the European Commission we should not certify OBL on OBL (and they do not like OBL at all)

So the solution is either a new OBL-certification directly in combination with the OEM, or a new brand name within the current OBL certification.

If you are still the declared manufacturer on the label and instructions for use, you can add the brand C to your certification.
Maybe you should redesign the label that there is a clear distinction between manufacturer (with the production plant symbol) and "distributed by company C". Just ask your NB.

.oO(I thought in GB any OBL would be easy cheesy)
Thread starter Similar threads Forum Replies Date
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
somashekar Own Brand Labelling (OBL) Agreement ISO 13485:2016 - Medical Device Quality Management Systems 4
R CE and UKCA marking Own Brand products CE Marking (Conformité Européene) / CB Scheme 0
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18
S OBL (Own Brand Labeling) - Full Quality to Production Quality EU Medical Device Regulations 5
L ISO 13485 and OBL (Own Brand Label) Agreement EU Medical Device Regulations 20
P OBL (Own Brand Label) - Annex III ? EC Type Examination EU Medical Device Regulations 2
A EC Certification Process and Time Frame for Own Brand Labeling Medical Devices EU Medical Device Regulations 4
V Own Brand Labeling Agreement/Contract Review ISO 13485:2016 - Medical Device Quality Management Systems 5
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3
D Recommendations for Own Brand Labeling Notified Bodies for Medical Devices EU Medical Device Regulations 6
S Piggybacking on OEM to become OBL (Own Brand Label) CE Marking (Conformité Européene) / CB Scheme 5
C Own Brand and Trademark Labeling Question EU Medical Device Regulations 10
P Further Own Brand Label questions - Urgent ISO 13485:2016 - Medical Device Quality Management Systems 6
D When is a device "Own Brand Labelled"? CE Marking (Conformité Européene) / CB Scheme 17
P Own Brand Labeling Issues ISO 13485:2016 - Medical Device Quality Management Systems 12
C Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessments EU Medical Device Regulations 3
R Technical File - Own Brand Labeling (OBL) Requirements EU Medical Device Regulations 16
B Building my own measurement equipment General Measurement Device and Calibration Topics 3
M Signed PSW directly to End customer, Tier 1 wants their own PPAP IATF 16949 - Automotive Quality Systems Standard 6
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
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 149
C Can we be our own EU authorised representative? EU Medical Device Regulations 34
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
S Internal Auditors shall not audit their own work? Internal Auditing 21
L Build own Power Magnetic Field Test Equipment for IEC 61000-4-8 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Building your own Leakage Current Tester IEC60990 Other US Medical Device Regulations 4
E "Internal" CAPA (Audit Nonconformance) Issuance to your own Department Nonconformance and Corrective Action 4
R Auditors can NOT audit their own work audit finding Internal Auditing 17
M IEC 60601-1 testing for device with its own 2V battery power supply necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D State Past Due on its own Meter Inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom