Label Translation SOP - MDD or ISO 13485 requirements?

S

SilverHawk

#1
Our TUV PS auditor issued us an NCR that there is no procedure on how label translation would be carried out. Our labeling are in English and we do not intent to sell our products to other EU members other than England. But TUV auditor insisted that we have to have a procedure for translation. We asked him under which MDD or ISO 13485 requirements that we have had to have such procedure. He just answered that it is in the MDD but we cannot find it.

The learnt experts, pls. advice on this concern.
 
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howste

Thaumaturge
Super Moderator
#2
Re: Label Translation SOP

The closest I can think of is a CMDCAS requirement (Canada). Even that one isn't talking about labels, but instructions:
Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
"It's there but I can't find it" is totally unacceptable

SilverHawk said:
We asked him under which MDD or ISO 13485 requirements that we have had to have such procedure. He just answered that it is in the MDD but we cannot find it.
If the auditor can't cite chapter and verse, so to speak, they can't give you a nonconformance. I'd go above the auditor by contacting the registrar and if they can't come up with a specific requirement, I'd contest it. I've seen auddits stopped in mid-audit over such nonsense, not to mention other stupid stuff.

I saw one auditor cite a client for ineffective internal audits because no nonconformances had been identified in over 2 years. The audit was stopped and the registrar was called. The client pointed out the there had been no findings by the registrars auditor over the previous 3 years. From that one would have to conclude that if the internal audits are ineffective because no nonconformances were found, the registrar's audits were also ineffective. Needless to say, that ended the auditor's nonconformance writeup.

Don't let an idiot auditor push you around. Require them to cite the specific requirement in the applicable standard. For an auditor to say "It's there but I can't find it" and to write a nonconformance is totally unacceptable. This is not an exercise in "Trust me".
 

Al Rosen

Staff member
Super Moderator
#4
Re: Label Translation SOP

howste said:
The closest I can think of is a CMDCAS requirement (Canada). Even that one isn't talking about labels, but instructions:
For medical devices the label contains instructions for use. Look at MDD Annex I 13. Article 4 #4 addresses the language requirements and does not require a procedure for translation.
 
W

wrodnigg

#6
From my humble opinion as (not TUV PS Lead Auditor ;) there is no requirement for a written procedure for translation of labels (and instructions for use).

There is a requirement for a procedure for document control (ISO 4.2.4). There is a requirement for a procedure for design control (ISO 7.3). But there is no requirement for a translation procedure in the ISO 13485 nor in the MDD!
There is no single sign of such a requirement in CMDCAS, Japanese or Taiwanese MD regulations.

Go tell your registrar to adress the specific requirement for such a procedure, or revoke this NCR (and the auditors license too).

You should decline this NCR and deprecate this auditor for the future (you have the right to do this).

~ghw

Best NCR of the year (I have been told): There is no validation (procedure/report) for dissolving a salt in water...
 
V

victoriab65

#7
The requirement can be found in NB-MED/2.5.2/Rec 3 Translation Procedure and in MEDDEV 2.5/5 Rev 3 Translation Procedure.

I have attached copies (they are free documents).

MEDDEVs are guidance documents published by the European Commission on specific aspects of the Medical Device Directive to ensure uniform understanding of the directives among manufacturers and notified bodies. They are guidelines and are not legally binding. They are drafted and approved by the Medical Devices Expert Group (MDEG) which consists of representatives from Competent Authorities, Notified Bodies and industry.
NB-MEDs are guidance documents for medical device manufacturers drafted by the NB-MED Group which consists of delegates from notified bodies which meet on a periodic basis.

Maybe you should send a copy of each to your auditor so they know where the idea came from? ;)
 

Attachments

Al Rosen

Staff member
Super Moderator
#8
victoriab65 said:
The requirement can be found in NB-MED/2.5.2/Rec 3 Translation Procedure and in MEDDEV 2.5/5 Rev 3 Translation Procedure.

I have attached copies (they are free documents).

MEDDEVs are guidance documents published by the European Commission on specific aspects of the Medical Device Directive to ensure uniform understanding of the directives among manufacturers and notified bodies. They are guidelines and are not legally binding. They are drafted and approved by the Medical Devices Expert Group (MDEG) which consists of representatives from Competent Authorities, Notified Bodies and industry.
NB-MEDs are guidance documents for medical device manufacturers drafted by the NB-MED Group which consists of delegates from notified bodies which meet on a periodic basis.

Maybe you should send a copy of each to your auditor so they know where the idea came from? ;)
I didn't see the word "documented" in either document.
 
R

Roland Cooke

#9
I don't think there is an NCR here - at least from the information provided.

However..........




The label copy must be in at least one (Member State) language according to the Directive. (Article 4.4)

4. 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.


Whilst the Directive is "only" a magazine article, it is the transposed law in each country that applies. However there is already precedent that CE marked devices that are not intended to be sold in Europe (yes it happens) must still have at least one Member State language, and must also have a European address / Authorised Representative.


Translations tend to be done by the manufacturer, or the distributor, or as a joint exercise.

In my opinion, translation is a manufacturing step (arguably a design step also), and thus must be controlled under Clause 7. If that activity is contracted out (i.e. to distributors) it must still be controlled.
After all, it is still the manufacturer's name on the box, it is still their CE-marked product. The manufacturer STILL bears responsibility.

There is of course of particular concern where the IFUs are complex and the distributors have (not unreasonably) a speciality in sales, rather than clinical matters or even language skills.

It is also important, even for low-risk devices, where the products are intended for home use.



I have raised NCRs where the English text filled one side, and there were 5 languages on the back. It didn't really matter whether or not I could personally understand those languages, it was obviously an inappropriate translation, perhaps even posing a safety risk.




Finally you can't raise NCRs against NB-MEDs or MEDDEVs per se. Note however that MEDDEVs are official guidance and should be followed unless a strong justification exists.
(The arguments I hear for not complying with the contained guidance tend to be pitiful. An NCR against either the MDD or ISO13485 usually follows in short order. :cool: )
 
Q

Quality Queen

#10
Talk about good timing - I got a similar comment on our documentation review today and I've been searching for "procedure" in the MDD all afternoon looking for the requirement. I should have started here...

What about a procedure for a CE Marking, Technical File, Declaration of Conformity? Do I actually need this? Can someone show me the shall!
 
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