SBS - The Best Value in QMS software

REF and CE mark symbols on multi-component device

#1
We have large device made of several component each shipped separately and then connected up / assembled into the Medical Device.
In this case I have considered the components to be Spare Parts of the overall Medical Device.

I am now wondering what the "REF" corresponds to in this scenario.

Does each of component have the REF symbol with the finished Medical Device reference number next to it
or
Does each component have the REF symbol with its own spare part reference number next to it?

Do I place the CE mark on one of the component or repeat it on all of them?

Thank you for your advice!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
How can they be considered "spare parts" if they're assembled into the final device? Are they required? If not, they may be accessories.

REF is the part number - what the customer would cite if ordering. If I understand correctly, each component would have a unique REF.

Not sure about the CE mark since unclear what these things are. Can you provide more details?
 
#3
Thanks Yodon, I will try to clarify.

Each part of the system is shipped separately and assembled at the hospital to have a fully functioning system.

So for example we would ship a camera, a cart, a CPU, a robot, and a remote separately (each component does not have a clinical purpose on its own), we would then assemble at the hospital them to make the device (which has a clinical purpose), and if any of the components we shipped was to malfunction we would send a replacement part.
All components are essential to the function of the device, which is why I would not consider them accessories.

Does this make more sense?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
You should look at the shipping as an internal step in your manufacturing process. The device is finished only once it's fully assembled at the hospital. This may have broad consequences on what you need to do, and how, for regulatory compliance. Once the device is assembled and finished you should apply a CE mark to the finished device / the system in a way that reasonably clarifies that it relates to the whole device / system.

The individual elements should not be CE marked as medical devices. If any other EU Directives or Regulations that include CE marking provisions (e.g. RoHS) are applicable, the relevant elements must comply and be CE marked accordingly. If none apply to an element, that element shouldn't be CE marked at all. To avoid trouble at border control etc., you may add clarifying statements on the labelling and accompanying administrative paperwork.

I agree with yodon that each element should bear its own part ID. Whether or not to use the REF symbol depends on the applicable Directives / Regulations.
 
Thread starter Similar threads Forum Replies Date
K REF symbol with product code in the IFU EU Medical Device Regulations 1
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
M Appropriate use of the REF symbol in IVD kits and kit components Other Medical Device Related Standards 2
Rameshwar25 Linearity Study - Tolerance for which Ref Value Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
hogheavenfarm Reference Distance - Print which shows "1.656 REF" as a dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A Linearity and Eccentricity Point Definitions - Ref: ISO/IEC 17025:2005 ISO 17025 related Discussions 1
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
G UVC sterilizer CE Mark CE Marking (Conformité Européene) / CB Scheme 5
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
A CE Mark and PMCF study EU Medical Device Regulations 3
T CE mark start date for a device EU Medical Device Regulations 7
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 23
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
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
A CE mark - Measuring Instruments Directive confusion! CE Marking (Conformité Européene) / CB Scheme 0
S CE mark on a medical device - Textile product CE Marking (Conformité Européene) / CB Scheme 2
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
S Can we still manufacture whilst awaiting return of our CE Mark? Other Medical Device Related Standards 1
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
B Do CE Mark associations exist? CE Marking (Conformité Européene) / CB Scheme 1
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
Ronen E RIP Mark Hollis 1955-2019 Coffee Break and Water Cooler Discussions 0
M CE mark validity after Brexit, 29th March '19 EU Medical Device Regulations 6
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
A CE Mark PPE Category III for our customers residing in the EU CE Marking (Conformité Européene) / CB Scheme 1
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10

Similar threads

Top Bottom