CE Mark Labeling Requirements for a Class II Medical Device

D

Dylansnow

#1
Is it mandatory to have the Manufactured symbol and date of manufacture on a CE marked class IIa device that has an expiry date. The expiry date is will be displayed.

Regards

Dylan
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
In short...No it isn't necessary


ER13.3(l) states: year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;

(e) states: where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;




You specify a useby date so therefore you are ok not to include the manufacture date.
 
A

Alexisss

#3
It depends on your product.

You shall place date of manufacture if the product is aging and its properties are affected as time passes during storage. For example, products containing natural rubber or adhesives or sterile packaging.

Even for rubber products, it is a delicate issue because it is different when you have medical gloves, for example, and different when you have a rubber part in a product.
 
Thread starter Similar threads Forum Replies Date
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
N Discontinuing using an Authorized Representative - CE Mark Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 21
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
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 17
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
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
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
D US Made class I CE Mark product for export only to EU Other US Medical Device Regulations 4
M ISO 13485 Required for CE Mark on Class I product CE Marking (Conformité Européene) / CB Scheme 1
O Private label issues For EU - Customer does not have CE Mark CE Marking (Conformité Européene) / CB Scheme 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1

Similar threads

Top Bottom