Regulatory Open Forum

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Good Morning Maude,

We were told by our AR and the outside firm that performs our internal audits that our translations had to be completed by a certified translator.  Their reasoning to us is that MDR 2017/245 requires that you follow all applicable regulations so that means that ISO 17100:2015 is required.

After those 2 inputs, we chose a translation company that was ISO 17100:2015 certified, provided reverse translation and have them listed on our critical supplier list.

We were never told anything about native language of the translator.  We were told that using our distributors in the specific companies was no longer an option due to the requirement of ISO 17100:2015.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Hello Michelle,

Thank you for your inputs. We also work with an ISO 17100 certified firm for our external translations so, this part is fine on our side. For internal reverse translation, we hired a professional translator. Could this be seen as non compliant to EU MDR if we are not certified to ISO 17100:2015?

Best regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Original Message:
Sent: 05-May-2022 07:15
From: D Michelle Williams
Subject: EU MDR Translation Compentency Requirements

Good Morning Maude,

We were told by our AR and the outside firm that performs our internal audits that our translations had to be completed by a certified translator.  Their reasoning to us is that MDR 2017/245 requires that you follow all applicable regulations so that means that ISO 17100:2015 is required.

After those 2 inputs, we chose a translation company that was ISO 17100:2015 certified, provided reverse translation and have them listed on our critical supplier list.

We were never told anything about native language of the translator.  We were told that using our distributors in the specific companies was no longer an option due to the requirement of ISO 17100:2015.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

It seems that ARs,  consulting/translation firms and some NBs keep making up new requirements.
There is no requirement in the MDR that states who should perform translations and no requirement that you must follow any standards.
ISO17100 is a standard that describes requirements for translation services, it's not a standard for manufacturers with requirements for how they should perform translation of labeling. This standard is/was not even harmonized.

I've worked with several professional translations firms, all had all kinds of certifications, certificates or experience with life sciences, yet on several occasions the translations they provided was garbage. It could be that we simply selected a wrong one for the job, but if we did that despite all the different standards and certifications the translators claimed, then I guess these standards have limited value.

Depending on your type of product and type of information you're translating, I would argue that in some cases performing base translation using Google Translate and then having a local expert review the translation will give you the same or better results than spending big $ with a translation firm.
Having an internal expert who is a native/fluent speaker is totally acceptable, or at least it should be.

------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs
Pittsburgh PA
------------------------------

Original Message:
Sent: 05-May-2022 07:15
From: D Michelle Williams
Subject: EU MDR Translation Compentency Requirements

Good Morning Maude,

We were told by our AR and the outside firm that performs our internal audits that our translations had to be completed by a certified translator.  Their reasoning to us is that MDR 2017/245 requires that you follow all applicable regulations so that means that ISO 17100:2015 is required.

After those 2 inputs, we chose a translation company that was ISO 17100:2015 certified, provided reverse translation and have them listed on our critical supplier list.

We were never told anything about native language of the translator.  We were told that using our distributors in the specific companies was no longer an option due to the requirement of ISO 17100:2015.

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

In a previous life, I was PM for a medical image viewer for PCP to review images from specialty workstations (CT, MRI). Sales and Marketing asked I  create catalog numbers for country-specific GUI options

Aside from the translation being a medically acceptable one (the word view could be translated differently for example a view on a monitor versus a view from the top of a hotel) and also spatial requirements in the translation are used within a GUI (Don't want letters clipped etc)

We chose a company that did translations specifically for Med Device.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Hi Maude, you would expect the AR to point to a specific provision in the MDR to raise this non-conformity against. For example for language article 10 (11) ("Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.").

No where in the MDR is this requirement of destination language as native language made, so I wonder where the AR gets this requirement from. In fact, if that were a requirement most of the EU's own translation services would break down (Finnish -> Greek,  Bulgarian -> Gaelic anyone?). Have you challenged them to provide a specific legal basis for the requirement? I would be interested to see what they come up with.

It's also not based on a harmonised standard and even then it would not be absolutely mandatory if you have a good alternative process. ISO 17100:2015 is not harmonised for the MDR, although it's always a good idea to have a translation company that can meet this standard. Treating the translation company as a critical supplier does make a lot of sense, and this is also wide seen because translations do affect the safety and performance of the device.

Best regards,

Erik

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

I thank you all for your responses, this clarifies and aligns.

To Erik, the Third Party did not gave a specific reference to the EU MDR as it was not the exact scope of the exercice.

Best regards,


------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Original Message:
Sent: 08-May-2022 02:21
From: Erik Vollebregt
Subject: EU MDR Translation Compentency Requirements

Hi Maude, you would expect the AR to point to a specific provision in the MDR to raise this non-conformity against. For example for language article 10 (11) ("Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.").

No where in the MDR is this requirement of destination language as native language made, so I wonder where the AR gets this requirement from. In fact, if that were a requirement most of the EU's own translation services would break down (Finnish -> Greek,  Bulgarian -> Gaelic anyone?). Have you challenged them to provide a specific legal basis for the requirement? I would be interested to see what they come up with.

It's also not based on a harmonised standard and even then it would not be absolutely mandatory if you have a good alternative process. ISO 17100:2015 is not harmonised for the MDR, although it's always a good idea to have a translation company that can meet this standard. Treating the translation company as a critical supplier does make a lot of sense, and this is also wide seen because translations do affect the safety and performance of the device.

Best regards,

Erik

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Dear Maude, 

EU MDR does have a provision requesting translations. It doesn't directly state what language they need to be translated and by whom, but it talks about the "Official language of the member state".  In certain areas, it also includes "upon request" by all types of actors (End-user, distributor, importer, competent authority, notified body).

EU MDR doesn't talk about ISO requirements but refers to "Harmonised Standards". 

When you look at EU MDR and ISO together, As a manufacturer, you must provide information for use(IFU), Labels and other documents( DoC, CE Certificate, technical files) as requested by the Actor in their official or required language. 

According to ISO 15223, Medical devices - Symbols - you need to use a Translation symbol on your labelling/IFU if you use a third-party translator; this is supported by ISO 17100, which talks about Human translators and how translations need to be done. 

Though there is no requirement to have an ISO 17100 accredited translation partner - As part of your QMS(/ISO 13485), you require to validate your critical suppliers; Where information supplied is treated as a critical element and if they are not translated by a qualified personal then it may have issues, hence having an ISO 17100 accredited translation agency acts as a qualification that you can keep on your supplier audit.

As a Regulatory consultancy and Translation agency, we have seen manufacture's using Google translate or Freelance translators who do not have full professional qualifications. This has caused specific issues for manufacturers who then hired us to redo the translation correctly. With ISO 17100, it is required for us as an agency to have a process in place where your document is translated by a translator -> reviewed by a reviewer -> proofread by a proof-reader then finally, project management by the project manager; hence each document is strictly going through 4 people who manage the translation process to ensure 99% accuracy.

hope this is clear. 



Links,
https://www.iso.org/obp/ui/#iso:grs:7000:3728

------------------------------
Chidambaram Radhakrishnan
CEO
www.omcmedical.com 
United Kingdom
------------------------------

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Hello Maude,

I agree with the other commenters that there are no clear requirements in the MDR about how translations are performed, and even ISO 17100 is optional. But I wanted to share our similar experience with our NB - in our case the auditor was hung up on the medical qualifications of the translator, to the point of insisting they must be a physician with expertise in our specific area. We were able to address this by performing a risk analysis of the translation process without committing to specific translator qualifications, as our translation firm told us this would be next to impossible to meet for some languages. 

It seems that some NBs are developing their own internal requirements around translations, which are sometimes far in excess of what the regulations actually require. 

Jennifer

------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Coquitlam, BC, Canada
------------------------------

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------

Years ago, I was told clinical evaluations could only be done by physicians, but now we have a guidance describing a team approach, where information professionals do the literature search, writers do the writing, and clinicians assess the premises and conclusions. We don't expect anyone to be expert in all those areas.

I agree a risk assessment is a good basis for a thoughtful translation process. If the danger is high and the vocabulary is esoteric, it may make sense to build glossaries and involve reviewers with relevant clinical expertise in each target country. If the device is low risk and the instructions use everyday vocabulary at 5th-grade level, a simpler process could be fine.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 09-May-2022 11:44
From: Jennifer Cabralda
Subject: EU MDR Translation Compentency Requirements

Hello Maude,

I agree with the other commenters that there are no clear requirements in the MDR about how translations are performed, and even ISO 17100 is optional. But I wanted to share our similar experience with our NB - in our case the auditor was hung up on the medical qualifications of the translator, to the point of insisting they must be a physician with expertise in our specific area. We were able to address this by performing a risk analysis of the translation process without committing to specific translator qualifications, as our translation firm told us this would be next to impossible to meet for some languages.

It seems that some NBs are developing their own internal requirements around translations, which are sometimes far in excess of what the regulations actually require.

Jennifer

------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Coquitlam, BC, Canada

Original Message:
Sent: 04-May-2022 11:50
From: Maude Thibault
Subject: EU MDR Translation Compentency Requirements

Dear RAPS Members,

Looking for inputs here. Was told by a Third Party that, under MDR (EU) 2017/245, a translation has to be performed by a person who's native language is that of the destination language.  It has not ended in an observation has it was out of scope so, I don't have a specific reference and I could not find a mention in the regulation. As someone heard the same, have inputs ?

Regards,

------------------------------
Maude Thibault
Regulatory Affairs
L'Islet QC
Canada
------------------------------