SBS - The best value in QMS software

Where can I find the MDD definition of Labeling?

Q

QA_RA_Lady

#1
Hi all,

I am looking for the exact definiton of labeling as stated by 93/42/eec. Does anyone know what or where this is, I'm getting ready to engage in a "discussion" with my marketing department and I'd really like to be able to site the reg when asked (and I will be asked)

Also I'm hearing a lot of rumble about no longer being able to provide IFUs and product in english in the EU... even when the device is for professional use... can anyone comment on that point?

Thanks,

QA_RA Lady
 
Elsmar Forum Sponsor
R

Reiko Shiratori

#2
Hi QA_RA Lady,

Requirements for labeling and IFU is in Annex I, 13 (13.1 to 13.6) of MDD (of course the amended one).

Regarding to IFU, I don't have enough information, so please wait other Covers opinions.

Reiko
 
B

blewispunk

#4
Attached is an export form a database I created with various regulations and then have classified by things like labeling. This is filtered on the MDD and Labeling so should have what you're looking for. Note that the entire reg may not be present as the field length may be exceeded but it gives the idea and will point you to the correct clauses.
 

Attachments

P

Persson - 2010

#5
Hi QA_RA Lady,

Requirements for labeling and IFU is in Annex I, 13 (13.1 to 13.6) of MDD (of course the amended one).

Regarding to IFU, I don't have enough information, so please wait other Covers opinions.

Reiko
Labeling means usually "Label + Instruction For Use."
 
R

Rolande Hall

#6
:notme::thanks:
Hi all,

I am looking for the exact definiton of labeling as stated by 93/42/eec. Does anyone know what or where this is, I'm getting ready to engage in a "discussion" with my marketing department and I'd really like to be able to site the reg when asked (and I will be asked)

Also I'm hearing a lot of rumble about no longer being able to provide IFUs and product in english in the EU... even when the device is for professional use... can anyone comment on that point?

Thanks,

QA_RA Lady
:thanx:

I must thank you and those replying for giving me the chance to say that the problem with this question is that it is not answered in the EU Medical Device Directives.
This is because the word "labeling" is an American word not used in UK English documentation. The Medical Device Directives refer to "label", "labels" and "labelling" but not "labeling". There is also a language compatibility issue in the German language text on this point.
I note that 'Persson' has correctly posted that Labeling means usually "Label + Instruction For Use.":thanks: Persson is clearly familiar with the American use of the word.
Relevent Terminology Definitions are as follows:
Labelling: information on the immediate or outer packaging (Ref: EU Council Directive 92/27/EEC of March 1992).
Label [1]: the USA Federal Food, Drug and Cosmetic Act in Section 201(k) defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article..."
Label [2]: ASTM, D 996 defines label as a piece of paper or other material to be affixed to a container or article, on which is printed a legend, information concerning the product, or addresses. It may also be printed directly on the container.
Labeling (1): the USA Federal Food, Drug and Cosmetic Act in Section 201(m) defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Labeling (2): written, printed, electronic or graphic matter affixed to a medical device or its packaging; or accompanying a medical device (ref: ISO 11607-1:2006 and ISO 11607-2: 2006).

Regarding the use of ENGLISH as the only language for Information Supplied by the manufacturer of medical devices, Council Directive 93/42/EEC states as follows:
" Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use."
To date, almost all Members States have demanded that the product label and IFU should be in one or more of their National languages.

The translators will never be made redundant.:nopity:
 
P

Persson - 2010

#7
:notme::thanks:

:thanx:

I must thank you and those replying for giving me the chance to say that the problem with this question is that it is not answered in the EU Medical Device Directives.
This is because the word "labeling" is an American word not used in UK English documentation. The Medical Device Directives refer to "label", "labels" and "labelling" but not "labeling". There is also a language compatibility issue in the German language text on this point.
I note that 'Persson' has correctly posted that Labeling means usually "Label + Instruction For Use.":thanks: Persson is clearly familiar with the American use of the word.
Relevent Terminology Definitions are as follows:
Labelling: information on the immediate or outer packaging (Ref: EU Council Directive 92/27/EEC of March 1992).
Label [1]: the USA Federal Food, Drug and Cosmetic Act in Section 201(k) defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article..."
Label [2]: ASTM, D 996 defines label as a piece of paper or other material to be affixed to a container or article, on which is printed a legend, information concerning the product, or addresses. It may also be printed directly on the container.
Labeling (1): the USA Federal Food, Drug and Cosmetic Act in Section 201(m) defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Labeling (2): written, printed, electronic or graphic matter affixed to a medical device or its packaging; or accompanying a medical device (ref: ISO 11607-1:2006 and ISO 11607-2: 2006).

Regarding the use of ENGLISH as the only language for Information Supplied by the manufacturer of medical devices, Council Directive 93/42/EEC states as follows:
" Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use."
To date, almost all Members States have demanded that the product label and IFU should be in one or more of their National languages.

The translators will never be made redundant.:nopity:
Thanks Rolande Hall!

As a matter of fact, the information I posted before was derived from an internal document supplied to us by our EC Rep, Wellkang Tech Consulting in London. The original wording from Wellkang is "Labelling means usually the Label plus the Instruction For Use except for the cases when Instruction For Use is not a compulsory requirement..."

I could not upload and share with you guys the document because it is copyrighted materials written by Wellkang consultants.
 
R

Reiko Shiratori

#8
Thank you Persson and Rolande,

Now I see, I should have used "label and IFU" in the thread.

Definitions are helpful. :thanx:

Reiko
 
Thread starter Similar threads Forum Replies Date
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
M Where can I find examples of PPAP? APQP and PPAP 6
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
M Plating standards - Where to find information AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
G Where I could find any project HSE plan templates Occupational Health & Safety Management Standards 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
I Where to find VDA 6.3 Robust Production Process (rpp) PDF file ? VDA Standards - Germany's Automotive Standards 1
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
J Where can I find a product's CE Mark Number? CE Marking (Conformité Européene) / CB Scheme 20
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Where to find ISO27000 Annex A? General Auditing Discussions 2
W Where to find the Daimler DBL 6992 10 new (old) standard Customer and Company Specific Requirements 1
V Where I can find an AAR form on Ford Covisint? APQP and PPAP 1
G Where to find the ANSI Z1.9 Rosetta Stone Capability, Accuracy and Stability - Processes, Machines, etc. 9
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
V Where to find Red/White Rust Rating Requirements? APQP and PPAP 4
P VDA 2 - Where to find EMPB (Erstmusterpr?fbericht) bilingual forms VDA Standards - Germany's Automotive Standards 2
K Where do I find Frequencies and Composite Scale in Minitab? Using Minitab Software 2
V Where do I find Adverse Event Database for Medical Devices? Quality Manager and Management Related Issues 2
S Where can I find a (Methods-Time Measurement) MTM-UAS Table? Human Factors and Ergonomics in Engineering 1
V Where to find FORD Specific PPAP Training Training - Internal, External, Online and Distance Learning 3
S Where can I find the World Bank Regulations Texts? Other ISO and International Standards and European Regulations 6
S Where can I find a list of CE Approved Products? CE Marking (Conformité Européene) / CB Scheme 4
J Where to find info about equivalent standards? ESD issues Other ISO and International Standards and European Regulations 4
B Where to find the 510(k) Device Listing Number 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K ISO Certified, now where to find work? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Marc Inspectors find safety flaws where airline food is prepared Travel - Hotels, Motels, Planes and Trains 5
J Where to find new GD&T (geometric dimensioning and tolerancing) standards? Various Other Specifications, Standards, and related Requirements 2
O Where to find FAA Part 21 Federal Aviation Administration (FAA) Standards and Requirements 3
G Where to find Ggg-g-17 - Spec is related to GAGE, FILLET AND RADIUS Customer and Company Specific Requirements 7
S Where to find MIL Standard 8A,8B - Used for Dimensioning and Tolerancing Quality Tools, Improvement and Analysis 3
D Where to find Customer Specific Requirements Customer and Company Specific Requirements 6
Q Where to find CFR 820/GMP Training DVDs Book, Video, Blog and Web Site Reviews and Recommendations 7
M Where to find Medical Software Products on the internet? Software Quality Assurance 3
J Bias example-about Df=10.8 - Where to find the df table Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R Where I can find a list of (Notified Chemical) substances? RoHS, REACH, ELV, IMDS and Restricted Substances 6

Similar threads

Top Bottom