Using of CE marking - Two CE markings on the product

#1
Hello, seniors, can anyone answer:
My product is a medical device. Due to certain factors, there are two CE markings on the product, which are in different positions. Is this feasible?
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Do you mean 2 CE Marks for the same directive/regulation? I can't see why this should be a problem provided the information is consistent. Or do you mean 2 CE Marks for different directives? that will probably be an issue.
 
#3
Yes, 2 CE marks for the same directive/regulation.

It should be said that one of my products complies with CE regulation, this product is composed of two components, but these two components are marked with CE respectively. Is it possible to do so?

If two CE marks are placed, I worry about it will be considered that these two different products are individually CE marked?
 

CharlieUK

Quite Involved in Discussions
#4
If two CE marks are placed, I worry about it will be considered that these two different products are individually CE marked?
I've not seen the product - but that is what it would look like - is it a problem if the product looks like a combination of two parts (each of which should have a DoC as they are CE marked) ?
 
#5
To be more specific, this is a prosthesis knee joint of medical device.....
Based on some factors, the head and body of the knee joint have CE marks(as below pic.), but this product itself is compliance with regulation MDR 2017/745. i don't know is it a problem that 2 CE marks in one product on two different part?
 

Attachments

#6
There is no maximum amount of icons in any regulation or standard, there is a minimum (1) :) A NB may argue that it is confusing to the user depending on the use case I suppose, but I've only ever had discussions on labels/icons being not visible enough ...

Regardless, as long as the icons meet requirements for size/dimensions, you can stick as many as you want on a product as far as I am aware regulations/standards wise. Only possible problem I see is that a good NB will question you on why there are two CE marks and you'll have to clarify this to them.

It looks like you are combining 2 products into 1? Do you own both designs or are you adding your own design to another parties desgin?
 
Thread starter Similar threads Forum Replies Date
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
P Using an ISO 9001 supplier for an ISO 13485 Company/CE Marking Other ISO and International Standards and European Regulations 1
B CE Marking using the ISO13485 Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 20
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 3
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
rerusk1 MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom