Regulatory Open Forum

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Hi Tosan

Up to my knowledge, you do not need to translate the label if you use ISO 15233 symbols on the label and explain the symbols in the IFU or on the companies eIFU page. I am not sure, but I think FDA has now also accepted the 15233 symbols without any explanatory text next to them on the label.

Bets regards,

Hans

------------------------------
Hans Strobel
CEO
dokspot GmbH
Zürich, Switzerland
www.dokspot.io
------------------------------

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Thank you Hans!

Tosan.


Original Message:
Sent: 1/10/2021 9:10:00 AM
From: Hans Strobel
Subject: RE: Label Translations for EU MDR

Hi Tosan

Up to my knowledge, you do not need to translate the label if you use ISO 15233 symbols on the label and explain the symbols in the IFU or on the companies eIFU page. I am not sure, but I think FDA has now also accepted the 15233 symbols without any explanatory text next to them on the label.

Bets regards,

Hans

------------------------------
Hans Strobel
CEO
dokspot GmbH
Zürich, Switzerland
www.dokspot.io
------------------------------

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Hello Tosan,

To add what Hans commented on using symbols on labels, is your direct device label or carton label should be structured or designed in a way to minimise the translation needs, e.g. using symbols.  In general, product name and company name are not required to be translated.  However, if you direct device label has additional statements or warnings on the label, then indeed these most likely would need to be translated.  A good label design is ensuring all the relevant and pertinent information is on the label without having blocks of text needing translated.  As an example, if there are warning statements which are only needed in actual use of device, the attention symbol on the label can be used and then the warning placed in the IFU/instructions/information provided to user which is then translated.  This may then not require many languages on the actual label.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Jan-2021 11:34
From: YASSER ESTAFANOUS
Subject: Label Translations for EU MDR

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Hi Tosan,

I agree with Richard as always, but I have to add that you have to comply with the language requirements of each country.
You have to do some searching and maybe contact the local authorities.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 11-Jan-2021 00:03
From: Richard Vincins
Subject: Label Translations for EU MDR

Hello Tosan,

To add what Hans commented on using symbols on labels, is your direct device label or carton label should be structured or designed in a way to minimise the translation needs, e.g. using symbols.  In general, product name and company name are not required to be translated.  However, if you direct device label has additional statements or warnings on the label, then indeed these most likely would need to be translated.  A good label design is ensuring all the relevant and pertinent information is on the label without having blocks of text needing translated.  As an example, if there are warning statements which are only needed in actual use of device, the attention symbol on the label can be used and then the warning placed in the IFU/instructions/information provided to user which is then translated.  This may then not require many languages on the actual label.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-Jan-2021 11:34
From: YASSER ESTAFANOUS
Subject: Label Translations for EU MDR

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Thank you Spyros.

Tosan.


Original Message:
Sent: 1/11/2021 2:42:00 AM
From: Spyros Drivelos
Subject: RE: Label Translations for EU MDR

Hi Tosan,

I agree with Richard as always, but I have to add that you have to comply with the language requirements of each country.
You have to do some searching and maybe contact the local authorities.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 11-Jan-2021 00:03
From: Richard Vincins
Subject: Label Translations for EU MDR

Hello Tosan,

To add what Hans commented on using symbols on labels, is your direct device label or carton label should be structured or designed in a way to minimise the translation needs, e.g. using symbols.  In general, product name and company name are not required to be translated.  However, if you direct device label has additional statements or warnings on the label, then indeed these most likely would need to be translated.  A good label design is ensuring all the relevant and pertinent information is on the label without having blocks of text needing translated.  As an example, if there are warning statements which are only needed in actual use of device, the attention symbol on the label can be used and then the warning placed in the IFU/instructions/information provided to user which is then translated.  This may then not require many languages on the actual label.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-Jan-2021 11:34
From: YASSER ESTAFANOUS
Subject: Label Translations for EU MDR

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Original Message:
Sent: 1/11/2021 12:03:00 AM
From: Richard Vincins
Subject: RE: Label Translations for EU MDR

Hello Tosan,

To add what Hans commented on using symbols on labels, is your direct device label or carton label should be structured or designed in a way to minimise the translation needs, e.g. using symbols.  In general, product name and company name are not required to be translated.  However, if you direct device label has additional statements or warnings on the label, then indeed these most likely would need to be translated.  A good label design is ensuring all the relevant and pertinent information is on the label without having blocks of text needing translated.  As an example, if there are warning statements which are only needed in actual use of device, the attention symbol on the label can be used and then the warning placed in the IFU/instructions/information provided to user which is then translated.  This may then not require many languages on the actual label.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Jan-2021 11:34
From: YASSER ESTAFANOUS
Subject: Label Translations for EU MDR

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Thank you Yasser.

Tosan.


Original Message:
Sent: 1/10/2021 11:34:00 AM
From: YASSER ESTAFANOUS
Subject: RE: Label Translations for EU MDR

Hi Tossan,
What I can say and that exactly what we are doing right now is all you need is to translate the IFU and the retail box (if applicable) to all languages  needed to market in different countries

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------

Hi
In some EU countries, they even require translations of device type or model names  in national laguage directly in the label. Translations or explanations of the symbols that appear on the label must be provided in the instructions for use /IFU/ in accordance with national legislation. It is therefore necessary to check national legislation in the EU, ie to contact national regulatory authorities.

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 09-Jan-2021 07:24
From: Tosan Eweka
Subject: Label Translations for EU MDR

Hi,

The company I work for distributes devices in several EU countries which official language is not English. We've typically always translated IFUs into the official languages of these countries but with the EU MDR requiring translations to labels, I am not sure how this can be executed without creating a different label for each non-English speaking country. Does anyone have feedback or ideas on how to meet the label translation requirement without creating labels for each country?

------------------------------
Tosan Eweka
Allen TX
United States
------------------------------