IFU (Instructions for Use) Label Symbols Requirements

C

Cinti

#11
Thank you for your reply. We are manufacturing IOLs. We have been printing all symbols that you listed out. My question is which symbol is printed in label, which symbol is printed in pouch, which symbol is printed in carton box and which symbol is printed in all (i.e.) label, pouch, carton box.
 
Elsmar Forum Sponsor
M

MIREGMGR

#12
Generally speaking, it's desirable for all the labels to contain the same content, except for the obvious differences in quantity that are related to unit pouch versus multi-unit carton.
 

RA Guy

Involved In Discussions
#13
Could you provide a link or reference to that restriction in HC's "Guidance for the Labelling of Medical Devices (...)" or the "Medical Device Regulations"?

As to languages...Section 23 of the "Medical Device Regulations" and Section 1.3 of "Guidance for the Labelling of Medical Devices (...)" both state that information required to be provided on a device label (except for manufacturer name/address and the product's identifying and batch-code numbers) shall be in English and French if the device is to be sold to the general public, and in either English or French or both if the device is for professional use only, with the device's IFU available to be provided in the other official language upon request. There is no mention in either document of Quebec specificity.
MIREGMGR, the mandated language requirement for French in Quebec is further addressed in Quebec's provincial language laws.


51. Every inscription on a product, on its container or on its wrapping, or on a document or object supplied with it, including the directions for use and the warranty certificates, must be drafted in French. This rule applies also to menus and wine lists.
The French inscription may be accompanied with a translation or translations, but no inscription in another language may be given greater prominence than that in French.
1977, c. 5, s. 51; 1997, c. 24, s. 24.

Sorry, but my junior status at this forum prevents me from posting the link to the provinicial laws, but if you Google "Title I : Status of the French Language" you should get to the full English version of the law.
 

Michael Malis

Quite Involved in Discussions
#14
Thank you for your reply. We are manufacturing IOLs. We have been printing all symbols that you listed out. My question is which symbol is printed in label, which symbol is printed in pouch, which symbol is printed in carton box and which symbol is printed in all (i.e.) label, pouch, carton box.
Hi Cinti,

You can copy symbols all over, however you will need a lot of label space...

I have a few questions that may help.
What is your intended market? North America only (US, Canada), European Community only (EU, but not the US) or both?
If the answer is the last, then the the minimum requirements are:
1. Use of symbols alone is not permitted for the North American market. product labeling using symbols must be accompanied by a legend defining the symbols used.

2. For all medical products requirements are:

Expiration date - symbols must be on all levels.
CE Mark with Notified Body No- as above
Single use only (do not reuse) - all levels
Name of Manufacturer - as above
MFG place of business/address - as above
Lot number/batch - as above
Sterility indication - as above (with appropriate Sterility Assurance level such as 10 to -6 or 10 to -3)
Cat/Reference number - as above
Rx Only (if applicable) - as above
Storage/Handling instructions - shelf and case, but not on the unit level if label space is limited (need to do risk assessment to verify...)
Directions for use/IFU - on shelf only
Cautions - as above (information is not required if label space is limited)
If package is damaged - shelf and case only (unit level is optional)
Name and address of Authorized Representative - as above

Please let me know if you have any questions.

Regards,
Mike
 
R

Real McCoy

#15
I have copies of all the symbols for IVDs, medical devices, but I'm having difficulty finding a standard for translations into all the languages for all the symbols (I do have some from EDMA but doesn't cover all relevant symbols). Is there such an animal? What I have seen from translators varies somewhat in translation from the English between same symbol. Would appreciate any input, thanks.
 
M

MIREGMGR

#16
MIREGMGR, the mandated language requirement for French in Quebec is further addressed in Quebec's provincial language laws.
51. Every inscription on a product, on its container or on its wrapping, or on a document or object supplied with it, including the directions for use and the warranty certificates, must be drafted in French. This rule applies also to menus and wine lists.
The French inscription may be accompanied with a translation or translations, but no inscription in another language may be given greater prominence than that in French.
1977, c. 5, s. 51; 1997, c. 24, s. 24.
Sorry, but my junior status at this forum prevents me from posting the link to the provinicial laws, but if you Google "Title I : Status of the French Language" you should get to the full English version of the law.
Nothing like a nearly three year delay in a thread discussion to keep matters moving...mea culpa. Somehow at the time I was diverted from this, but now it is of renewed interest for me.

Section 56 of the same law (albeit in the English version) says:
56. If the documents referred to in section 51 are required by any Act, order in council or government regulation, they may be excepted from the rule enunciated in that section, provided that the languages in which they are drafted are the subject of a federal-provincial, interprovincial or international agreement.
The Federal "Medical Device Regulations", SOR/98-282, say in Section 23 (1) (in the English version):
23. Subject to subsection (3) [which defines a separate rule for OTC/consumer medical devices], the information required by subsection 21(1) [i.e. the required medical device label information] shall, as a minimum, be in either English or French.
So, my questions: Under Canadian constitutional rules, do the Federal Medical Device Regulations constitute a federal-provincial agreement? Or, if not, has there been some other resolution of this legal conflict?
 

Chrisx

Involved In Discussions
#17
This topic came up when I took my training from Accademia Qualitas to become certified as an auditor for CMDCAS. This training is given by staff from Health Canada for employees of Health Canada Recogized Registrars. Sorry, I can't remeber who the trainer was. The trainer said that Health Canada does not recognize any symbols. Symbols must be explained in the IFU.

There is nothing in the regulation that specifically states this. However, Health Canada does not have any recognized standards for symbols (e.g. EN 980, ISO 15223). I think it is the absence of any recognized standard that conveys that no symbol is recognized.
 
Thread starter Similar threads Forum Replies Date
Q Instructions for Use (IFU) - On the Manufacturer's Website vs. On the Product Label US Food and Drug Administration (FDA) 15
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ajit Basrur Incoming Inspection for Instructions for Use (IFU) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
D 207/2012 Update for MDR (?) - Instructions for Use (IFU) EU Medical Device Regulations 9
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Domestic and International Medical Device IFU (Instructions for Use) Other US Medical Device Regulations 3
G Medical Device IFU (Instructions for Use) Translation Requirements EU Medical Device Regulations 4
E Changes to IFU (Instructions for Use) on a CE Marked Medical Device ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
sagai Electronic Instructions for Use (IFU) of Medical Devices EU Medical Device Regulations 10
T Providing Instructions for Use (IFU) vs. 'Help' pages 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P EU Electronic IFU (Instructions for Use) Requirements EU Medical Device Regulations 2
L Device Description in CSDT Format - Medical Device Instructions for Use (IFU) Other Medical Device Regulations World-Wide 6
C Authorized Representative Contact Information in IFU (Instructions for Use) EU Medical Device Regulations 2
S Can we put two Manufacturer's address in IFU (Instructions For Use)? CE Marking (Conformité Européene) / CB Scheme 2
O Harmonized Standards on Medical Device IFU (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 7
G IFU (Instructions for Use) - Labeling Requirements EU Medical Device Regulations 1
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
J EU 207/2012 E-IFU Service Video EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
K No IFU, where the requirements would go? EU Medical Device Regulations 5
P IFU Translation Requirements for EU EU Medical Device Regulations 2
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
K REF symbol with product code in the IFU EU Medical Device Regulations 1
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
H IFU in different language other than English EU Medical Device Regulations 5
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
K Label - IFU requirement, maybe? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Electrosurgical devices/surgery IFU contraindications EU Medical Device Regulations 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom