Medical Device no CE mark ship to US Base in Europe

B

Brickway500

#1
Can a class 2 or 3 medical device be shipped to a US base in Europe without a CE mark? If so what would be the process? Note: both class of devices are approved in US. Are there any standards that could help me with this issue? :confused:

Thank you for your help!
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Interesting question, if you had sold the equipment to the military then they had brought it with them would they classed as an importer?
The answer will revolve around whether this is being classed as being "placed on the market" in Europe, if it is then yes the product will need CE marking. Best speak to the notified body of the country the base is in.
This link gives contact details http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=na.main
Good luck.
rob
 

somashekar

Staff member
Super Moderator
#3
Can a class 2 or 3 medical device be shipped to a US base in Europe without a CE mark? If so what would be the process? Note: both class of devices are approved in US. Are there any standards that could help me with this issue? :confused:

Thank you for your help!
Somewhere within the contract agreement for the establishment of the US base in EU, this aspect would have been addressed. This does not constitute placing in the market.
Also depends who is the importer and exporter in this instant, and the purpose of importing.
 
Last edited:
Thread starter Similar threads Forum Replies Date
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
S CE mark on a medical device - Textile product CE Marking (Conformité Européene) / CB Scheme 2
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
F CE and FDA Mark on same IVD/Medical Device Label EU Medical Device Regulations 12
P Approval process for modifications to a medical device with a CE Mark CE Marking (Conformité Européene) / CB Scheme 5
C CE Mark Label Symbol Requirements on a Medical Device CE Marking (Conformité Européene) / CB Scheme 3
A Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 14
I Legitimate Medical Device System CE Mark based upon Supplier CE Mark(s) Other Medical Device and Orthopedic Related Topics 4
A ROHS and CE Mark - Requirements for a Class IIa Medical Device EU Medical Device Regulations 6
E Medical Device Class 2a CE Mark Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 3
A Design Company - CE Mark for a Medical Device Class 2A , Annex VI & Annex VII EU Medical Device Regulations 12
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
J Question about CE mark for Dental Gel which is probably Medical Device Class 2a EU Medical Device Regulations 2
N Medical Device PIT (Physician Initiated Trial) Study without CE Mark EU Medical Device Regulations 3
D CE Mark Labeling Requirements for a Class II Medical Device EU Medical Device Regulations 3
B Does Saudi Arabia mandate that a CE Mark for a Medical Device is Required? Other Medical Device Regulations World-Wide 10
rob73 Transfer of Technical File, CE Mark etc., for an OEM Medical Device EU Medical Device Regulations 3
C IEC 60601 vs. CE Mark HMIs - Which should be used for a Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Launching a CE Mark Class I (non-measuring and non-sterilzed) Medical Device EU Medical Device Regulations 1
D Training on IEC 62366 (Medical Device Usability Engineering) for CE Mark? IEC 62366 - Medical Device Usability Engineering 5
C CE Mark of a purchased Medical Device with different IFU EU Medical Device Regulations 7
S Medical Device Technical File/Dossier (CE Mark) review - How many ?experts? available CE Marking (Conformité Européene) / CB Scheme 3
S Medical Device placed on the market with no CE Mark - Consequences? CE Marking (Conformité Européene) / CB Scheme 22
B Does a Medical Device Battery need CE Mark CE Marking (Conformité Européene) / CB Scheme 20
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
E How to get FDA Approval for Class II Medical Device - We have CE Mark, 13485, 9001 US Food and Drug Administration (FDA) 12
M IEC 60601 vs. IEC 61010 - CE Mark for our IVD medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
K CE Mark on Promotional Material (Brochure for our Medical Device) EU Medical Device Regulations 7
somashekar Follow-up audit after safety mark authorization (Medical device) ISO 13485:2016 - Medical Device Quality Management Systems 2
L When IEC 60601-1 2nd edition can not be used for CE mark medical device application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Where to CE Mark a Class I medical device the size of a small tablet EU Medical Device Regulations 1
N Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark? ISO 13485:2016 - Medical Device Quality Management Systems 5
somashekar Mark on Medical device label marketed in Canada ISO 13485:2016 - Medical Device Quality Management Systems 1
M CE Mark Size Requirement - Class I Medical Device EU Medical Device Regulations 8
R Medical Device Vigilance System Requirements - CE Mark Products EU Medical Device Regulations 4
J Class III Medical Device with CE Mark Approval - India Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 10
Marc CE Mark Myths - The Medical Device Directive's Seven Major Myths EU Medical Device Regulations 8
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6

Similar threads

Top Bottom