MDD 2007/47/EEC - Medical Device Directive Labeling Changes

D

Dudes

#11
Re: 2007/47/EEC MDD Labeling Changes

(i am writing from own experiences, with labels and also with competitors who opened sterile pouches, placed mosquitos and resealed them!).
:mg: I know it's not really the topic, but I'd love to hear the full story :eek:
 
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M

medsandiego

#12
Re: 2007/47/EEC MDD Labeling Changes

can anyone clarify the interpretation of the 'date of issue or the latest revision of the instructions for use'.....does this mean

1. we have to include a revision number/letter on the IFU in the format of
Label/Doc/Material Number xxxxxx_rev00, even if the base revision is 00 and is currently presented on the IFU only as the label number "xxxxxx" and the rev00 is dropped; for all changes to IFUs we issue a new label (artwork) number so they never would appear xxxxxx_01

OR

2. we need to control issue dates or revisions of IFU's within our document control system so we can have revision control and ensure the end user always has the latest version, but they are not specifically concerned with a revision or issue date on the actual IFU itself.

Hopefully this is clear, but these are two separate interpretations we have within our company and depending on which way it goes impacts if we have to revise each individual IFU

Thanks:)
 

Michael Malis

Quite Involved in Discussions
#13
Re: 2007/47/EEC MDD Labeling Changes

can anyone clarify the interpretation ...

1. we have to include a revision number/letter on the IFU in the format of
Label/Doc/Material Number xxxxxx_rev00, even if the base revision is 00 and is currently presented on the IFU only as the label number "xxxxxx" and the rev00 is dropped; for all changes to IFUs we issue a new label (artwork) number so they never would appear xxxxxx_01

OR

2. we need to control issue dates or revisions of IFU's within our document control system so we can have revision control and ensure the end user always has the latest version, but they are not specifically concerned with a revision or issue date on the actual IFU itself.

Hopefully this is clear, but these are two separate interpretations we have within our company and depending on which way it goes impacts if we have to revise each individual IFU

Thanks:)
Medsandiego,

No - It is not clear...but:
You need to control the revisions in your system and make sure that your customer get the latest IFU.
Your # 2 is maybe OK on the surface however, if the is no revision control on the IFU, how your people in the warehouse will differentiate revision 1 from rev. 2 and provide the latest to the customer???
 
A

Alexisss

#14
Re: 2007/47/EEC MDD Labeling Changes

Further to Michael's comment:

not only the warehouse people will not know what to include, but also doctors and end-users.

Imagine the case where you have a change in the way that you set-up an ECG loop recorder, and now you need to press a different combination of buttons in order to enter the settings mode of the device. The doctor knows the "old" IFU. If you do not mention anything like revision (and even "date" in my opinion) that will enable the doctor to compare the IFUs, it will take the doctor long to find out what is happening.

And having usability and the human factor in mind, one must also foresee the foolishness of a user (iso/iec 62366), therefore my suggestion is to find a way of telling him "helloooo new instructionssss.... hellooooo.... " (may be change the colour of the cover page of the IFU for example).
 
J

JEKeller

#16
Documentation for Medical Devices intended for sale in Italy must have a translated IFU, labels, manuals, etc. Must the software driving a device also be translated into Italian based on the new Medical Device requirements?
 

Michael Malis

Quite Involved in Discussions
#17
Documentation for Medical Devices intended for sale in Italy must have a translated IFU, labels, manuals, etc. Must the software driving a device also be translated into Italian based on the new Medical Device requirements?
Please clarify the product type, but generally speaking, software must be validated and translation is not required.
 
J

JEKeller

#18
The software drives the operation of a surgical device that receives input from an on-board navigation system.
 
C

CarloCat

#19
Please clarify the product type, but generally speaking, software must be validated and translation is not required.
Hi,
from regulatory point of view, if software a device itself or it is part of the device, and if you can't use symbols, you have to tranlsate it in the Italian language and in all the European languages where you sell the software.

I'm italian and I know that probably not too many controls will be done to check the software language requirements, but it could happen that some professionals users can ask for the User manual and the information on the software in italian language. Please consider that lots of italian people don't speak english well and they could require it even just for their own understanding. So this is , also, a marketing point of view.
Let me know if you may need furthe information
Bye
Carlo
 
Y

yana prus

#20
Hi,

I agree with Carlo. As appears in "MDEG - 2008-12 - II-6.3. Mandatory Languages Requirements for Medical Devices", Display (GUI) has to be tranlsated to Italian. Some NB auditors check during the audits that the company is aware of this guidance (like this guidance appears in the list of applicable standards), and that translation was actually performed.

Regards,

Yana
 

Attachments

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somashekar Revisions to the MDD 93/42/EEC published as Directive 2007/47/EC EU Medical Device Regulations 5
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W Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC EU Medical Device Regulations 2
W Revision of MDD 93/42/EEC, AIMD 90/385/EEC and BPD 98/8/EC published: 2007/47/EC ISO 13485:2016 - Medical Device Quality Management Systems 8
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