Medical Device CE Marking - Using a disposable bearing

Udirn1

Starting to get Involved
#1
Hi All,
I have a medical device class IIB bearing a medical ce symbol.the same device uses a disposable which bears a medical ce as well.
This device is also sold outside the eu without the medical ce label on it, and its accessories , but the consumables still bears the medical ce symbol.

Is there any problem using a disposable bearing a medical ce mark on a device not bearing it?
Thanks
Udi
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Not sure I completely follow but only the EU cares about the CE mark. For distribution in other countries, you need to understand what their market clearance requirements and labeling particulars are. The US, for example, will not "reject" a device if it has the CE mark but it's not a requirement.
 

Udirn1

Starting to get Involved
#3
Thanks,
Let me clarify.
If you have a device which is not ce marked regardless where its sold, can u use with it an accessory which is ce cleared? This mix is valid?
As far as I know, if the device is not labelled, all its components should not be labelled as well .
 

yodon

Staff member
Super Moderator
#4
Again, the CE mark is only relevant for the EU. The "regardless where it's sold" angle is not valid - you have to comply with the regulations of the country in which you want to distribute. For example, in the US, both the device and accessory would need to be cleared. If they're both cleared and one has a CE mark but the other doesn't, I don't think that would be an issue because they are both cleared. (And, of course, to get clearance, both must meet the labeling requirements of the country.)
 
Thread starter Similar threads Forum Replies Date
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
F CE Marking Algorithm for an IVD use only Medical Device EU Medical Device Regulations 7
M Partial Compliance to an ISO Standard for Medical Device CE Marking EU Medical Device Regulations 13
P Medical Device Marking - Power Input Ports IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II & III ISO 13485:2016 - Medical Device Quality Management Systems 3
T Risk Analysis help for CE Marking Class I Medical Device ISO 14971 - Medical Device Risk Management 10
T CE Marking Medical Device and classification CE Marking (Conformité Européene) / CB Scheme 6
A Tests required for CE Marking a Class 2A Medical Device EU Medical Device Regulations 6
5 Help with Medical Device Class IIa Annex V CE Marking Document Control Systems, Procedures, Forms and Templates 1
P Class 1 Medical Device Labeling and CE Marking Requirement EU Medical Device Regulations 8
B Question for CE Marking of Medical Device (Directive 93/42/EEC) EU Medical Device Regulations 2
R Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
B CE Marking Components of a Medical Device CE Marking (Conformité Européene) / CB Scheme 2
B CE-Marking on Class III Medical Device Products: How? CE Marking (Conformité Européene) / CB Scheme 5
A CE Marking - Annex II Requirements for Class IIa Medical Device EU Medical Device Regulations 5
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
E IEC/EN 60601 Testing and CE Marking for a Non Medical Device CE Marking (Conformité Européene) / CB Scheme 11
bio_subbu Basic Primer on how to obtain European CE Marking for a Medical Device EU Medical Device Regulations 0
V CE Marking for Device under (Research and Education) Non Medical. CE Marking (Conformité Européene) / CB Scheme 3
M Medical Device Variants submission for CE Marking - Class II Medical Device EU Medical Device Regulations 8
J CE Marking a CE marked Class I Medical Device - To aid approval/registration in China EU Medical Device Regulations 7
N CE Marking Medical Device with Software - together or separate? EU Medical Device Regulations 4
L CE marking on medical device components/replacement parts EU Medical Device Regulations 5
R CE Marking for Research Instruments - Small Company - Class II Medical Device EU Medical Device Regulations 3
K Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device EU Medical Device Regulations 11
N Could anybody suggest a routemap for CE marking for invitrodiagnostic medical device? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Class I Medical Device - What is in a CE Marking Self-Declaration EU Medical Device Regulations 18
V CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11 EU Medical Device Regulations 3
C CE marking - Medical Device - Must have our name and address on it? EU Medical Device Regulations 4
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4

Similar threads

Top Bottom