CE Marking components within IVD

#1
We sell some products that have calibrators provided in separate vials within the kit box. They are not for sale individually and must be used with the other reagents provided. The rest of the reagents are packaged together in a frame and that label does have a CE mark, as well as the box. If we could leave the CE mark off the calibrator vials it would be tremendously helpful to logistics and manufacturing as we transition from IVDD to IVDR. (This would avoiding relabeling. The current labels have no CE mark now (for right or wrong!) and even if we added it, we cannot add our Notified Body number yet as the certificate is not issued yet.)

Can we justify not putting a CE mark on the calibrator vials? We have two schools of thought - some say they MUST have the CE mark as part of the product. Others say they should NOT be labeled with the CE mark because they are not for sale themselves and the declaration is for the whole kit, not the the calibrators.

Thoughts?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H CE Marking on Multiple-Components Medical Products EU Medical Device Regulations 8
B CE Marking Components of a Medical Device CE Marking (Conformité Européene) / CB Scheme 2
C CE Marking for PCB Components for Laser Printer Cartridges CE Marking (Conformité Européene) / CB Scheme 5
W CE Marking based on components CE CE Marking (Conformité Européene) / CB Scheme 4
L CE marking on medical device components/replacement parts EU Medical Device Regulations 10
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
M CE marking for RUO products EU Medical Device Regulations 0
P CE marking time CE Marking (Conformité Européene) / CB Scheme 5
H Marking of Resin Identification Code CE Marking (Conformité Européene) / CB Scheme 0
G UKCA and EU MDR marking UK Medical Device Regulations 5
A Distributors with stock of expired CE marking EU Medical Device Regulations 2
D Direct-Marking Requirements under MDR 2017/745 EU Medical Device Regulations 3
R CE marking of products not sold into the EU CE Marking (Conformité Européene) / CB Scheme 4
J UKCA direct marking implementation UK Medical Device Regulations 0
Y CE marking with NB identification number EU Medical Device Regulations 0
B ASTM A53 Marking of length on recut pipes by processor Manufacturing and Related Processes 11
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Device with different options for a sub-component - CE marking implications EU Medical Device Regulations 2
R CE and UKCA marking Own Brand products CE Marking (Conformité Européene) / CB Scheme 0
C CE Marking - Medical Device Accessories EU Medical Device Regulations 3
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
F Lithium polymer battery, venting and CE Marking CE Marking (Conformité Européene) / CB Scheme 4
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
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
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
S CE marking for OEM Brand CE Marking (Conformité Européene) / CB Scheme 11
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
G CE marking of MD and IVD set EU Medical Device Regulations 3
M CE marking for NON-EU EU Medical Device Regulations 0
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
S CE marking for a product upgrade CE Marking (Conformité Européene) / CB Scheme 0
P CE Marking UK Membership CE Marking (Conformité Européene) / CB Scheme 1
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
Q EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Clinical investigations of medical devices - not for CE marking EU Medical Device Regulations 0
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5

Similar threads

Top Bottom