Own brand labelling/virtual manufacture of IVD's


Starting to get Involved
I would like some clarification please on what constitutes being " the manufacturer" of a self test IVD under the EU regulations. My company is currently negotiating the purchase of another small company (A) who assemble self test IVD's and distribute them under their own brand name but naming the OEM (B) on the packaging as the manufacturer and the packaging has the words "distributed by" (A) on it. Company A has ISO 13485. My belief is that company A is "the manufacturer" of these products and should hold the CE mark as they are assembling and selling them as their own brand but they argue that as the OEM is clearly stated on the box as the manufacturer and they just put "distributed by" them then they are not liable for the CE marking. It is my belief that the CE mark purely applies to the IVD device, not the test kit itself. They say audits of their ISO13485 system have not flagged up concerns about this.Because of confidentially issues I cannot at present approach the OEM for clarification. I would really appreciate advice please. Thank you.

PS I appear to have somehow posted this under the China regulations forum by mistake but am not sure how to correct this error and post under the EU regulations heading, sorry.
Last edited:
Elsmar Forum Sponsor


The post is a bit confusing.

One interpretation of your post is that OEM (B) is the legal manufacturer responsible for CE mark, and the original label reflecting that. The Company (A), without covering or changing the existing label, adds its own address and contact details to the device or packaging - is the distributor. Also, the original label itself can mention Manufactured By and Distributed By.

If however, the Company (A) is assembles or repackages or relabels, then it is the legal manufacturer.

What business is your company in - manufacturing or distribution?


Starting to get Involved
Thank you for your reply, sorry if I did not make it clear. Company A buys self test CE marked devices from manufacturer B. They assemble these devices with other components into kits which they sell under their (Company A's) own brand name, but place the OEM's details beside the manufacturer symbol on the packaging and state "distributed by" and their (company [email protected]) name and contact details.

My company assembles IVD tests under contract from OEM's but not own label. We are looking to purchase company A but if this would entail CE marking their products if they are not legally on the market this would obviously entail significant cost to us. I guess my main question is does declaring the OEM as manufacturer on the packaging and naming themselves as distributor remove their responsibilities to CE mark the kit, even if it is sold under their (the assembler's) brand name?
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
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
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
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 13
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
Richard Regalado BYOD (Bring Your Own Device) Policy by UK Information Commissioner's Office IEC 27001 - Information Security Management Systems (ISMS) 0
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Customer using their own version of the AIAG PPAP Forms APQP and PPAP 5

Similar threads

Top Bottom