CE mark start date for a device

T

tiptoe

Starting to get Involved
#1
#1
Dear all,

We have a CE mark that was issued in 2005 for one category of device. Under that category we have different devices that fall under it, how they were manufactured in different years (device 1 in 2005 and device 2 in 2010). In such a situation what date (CE start date) should I use for device 2. Will it be the initial year 2005 the CE mark was originally issued or 2010 when the device was manufactured?


Thank you
 
Download Free White Paper
Elsmar Forum Sponsor
T

tiptoe

Starting to get Involved
#5
#5
Ronen, thanks that's a good point raised there. So there's no specific requirement that states to note the CE mark start date on the DoC, but the requirement also states 'Where applicable, additional information;' so with that I believe the initial author may have added that due to the above statement.

So your recommendation will be take that out, I presume? Thank you
 
S

Sicco

Involved In Discussions
#7
#7
There is no legislative requirement to have such information in EU version of DoC. So in your position I would not over complicated it and I would stated only the mandatory requirements in the DoC in many cases less information is more.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
A Positive Experiences with CE Mark Consultants? CE Marking (Conformité Européene) / CB Scheme 1
A CE mark symbol should be on the package? EU Medical Device Regulations 1
A Medical Device including a smartphone - CE mark ? CE Marking (Conformité Européene) / CB Scheme 4
V SaMD/MDSW - Class I - CE Mark CE Marking (Conformité Européene) / CB Scheme 1
H Is it a requirement for run charts to have inspection data or can it have just a pass/fail check mark Records and Data - Quality, Legal and Other Evidence 4
R Class I MDSW CE Mark CE Marking (Conformité Européene) / CB Scheme 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
A CE-Mark regulatory advice - US based Organization CE Marking (Conformité Européene) / CB Scheme 6
H Regarding EAC-MED mark Other Medical Device Regulations World-Wide 0
H Relation of VDE mark with CE certification CE Marking (Conformité Européene) / CB Scheme 11
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
K Not keeping CE mark for some devices CE Marking (Conformité Européene) / CB Scheme 1
H Regarding the validity of EMC & Safety test reports without NABL & ILAC-MRA mark. CE Marking (Conformité Européene) / CB Scheme 2
G Remove & Reapply Laser Mark on Steel Manufacturing and Related Processes 1
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
S Clinical trial requirements for UKCA mark in UK UK Medical Device Regulations 4
H Notified Body Number with CE Mark CE Marking (Conformité Européene) / CB Scheme 4
H Production Validation- CE Mark ISO 13485:2016 - Medical Device Quality Management Systems 3
L CE Mark on Kit label AND inner label? EU Medical Device Regulations 1
T CE-IVD mark on packaging EU Medical Device Regulations 1
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
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 4
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
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
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom