Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold. 

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor? 

Thank you all for you time and I look forward to hearing your feedback. 

Hello,

Per Article 10 of MDR: "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."

This a manufacturer requirement and MDR auditors expect to see a documented process around translation as part of MDR QMS audits and/or technical documentation reviews.

If translations are something that is outsourced by your company, you should follow your supplier management procedures as you would for any other outsourced process/service. Similarly, you will want to ensure that the entity doing translations on your behalf is qualified to translate labeling content for medical devices. Your distributor may or may not be qualified to do that, but you must conduct the appropriate evaluations to ensure you have control of your translation process.

There is a thread on this forum titled "Professional labeling translators - What shall I look for ?" that you should review.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

Hello Hiral,

Does this apply to the individual package label on the parts? I am getting a lot of push back at my company. Currently we have our IFU translated in the languages of the Member state and an eIFU website. These are translated by an ISO 17100:2015 certified translator. 

Thank you,

Tiffany

------------------------------
Tiffany Irwin
Quality and Regulatory Engineer
Traverse City MI
United States
------------------------------

Original Message:
Sent: 29-Mar-2021 18:37
From: Hiral Dutia
Subject: EU MDR Label

Hello,

Per Article 10 of MDR: "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."

This a manufacturer requirement and MDR auditors expect to see a documented process around translation as part of MDR QMS audits and/or technical documentation reviews.

If translations are something that is outsourced by your company, you should follow your supplier management procedures as you would for any other outsourced process/service. Similarly, you will want to ensure that the entity doing translations on your behalf is qualified to translate labeling content for medical devices. Your distributor may or may not be qualified to do that, but you must conduct the appropriate evaluations to ensure you have control of your translation process.

There is a thread on this forum titled "Professional labeling translators - What shall I look for ?" that you should review.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

Hi Tiffany, yes, "labeling" constitutes all written and graphic material accompanying the device, and the expectation that labeling needs to be translated applies to all labeling.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 30-Mar-2021 07:03
From: Tiffany Irwin
Subject: EU MDR Label

Hello Hiral,

Does this apply to the individual package label on the parts? I am getting a lot of push back at my company. Currently we have our IFU translated in the languages of the Member state and an eIFU website. These are translated by an ISO 17100:2015 certified translator.

Thank you,

Tiffany

------------------------------
Tiffany Irwin
Quality and Regulatory Engineer
Traverse City MI
United States

Original Message:
Sent: 29-Mar-2021 18:37
From: Hiral Dutia
Subject: EU MDR Label

Hello,

Per Article 10 of MDR: "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."

This a manufacturer requirement and MDR auditors expect to see a documented process around translation as part of MDR QMS audits and/or technical documentation reviews.

If translations are something that is outsourced by your company, you should follow your supplier management procedures as you would for any other outsourced process/service. Similarly, you will want to ensure that the entity doing translations on your behalf is qualified to translate labeling content for medical devices. Your distributor may or may not be qualified to do that, but you must conduct the appropriate evaluations to ensure you have control of your translation process.

There is a thread on this forum titled "Professional labeling translators - What shall I look for ?" that you should review.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

Hi Tiffany - if you have limited real estate on your labels, one approach we have used is putting a box around the words on the label that would need translation and including these as symbols in the IFU glossary (essentially turning them into symbols). Of course this wouldn't work for long blocks of text, but it's good for individual words or short phrases. 

Jennifer

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

Original Message:
Sent: 30-Mar-2021 07:03
From: Tiffany Irwin
Subject: EU MDR Label

Hello Hiral,

Does this apply to the individual package label on the parts? I am getting a lot of push back at my company. Currently we have our IFU translated in the languages of the Member state and an eIFU website. These are translated by an ISO 17100:2015 certified translator.

Thank you,

Tiffany

------------------------------
Tiffany Irwin
Quality and Regulatory Engineer
Traverse City MI
United States

Original Message:
Sent: 29-Mar-2021 18:37
From: Hiral Dutia
Subject: EU MDR Label

Hello,

Per Article 10 of MDR: "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."

This a manufacturer requirement and MDR auditors expect to see a documented process around translation as part of MDR QMS audits and/or technical documentation reviews.

If translations are something that is outsourced by your company, you should follow your supplier management procedures as you would for any other outsourced process/service. Similarly, you will want to ensure that the entity doing translations on your behalf is qualified to translate labeling content for medical devices. Your distributor may or may not be qualified to do that, but you must conduct the appropriate evaluations to ensure you have control of your translation process.

There is a thread on this forum titled "Professional labeling translators - What shall I look for ?" that you should review.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

Hello,


There are companies who provide such translation services, you can outsource this job to them by following your internal procedures. If you are not familiar with any in the US, then you can reach out to your distributor or EU-Rep to find you a suitable one. While outsourcing this job, make sure they have enough experience and expertise in translating medical terminologies.

------------------------------
Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan
------------------------------

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

Hello Anon,

Indeed you need to have translation of labelling made for the local language according to the EU MDR.  Keep in mind labelling constitutes many different components like direct device labels, instructions for use, computer screens, user interfaces, etc., so the use of symbols is also quite helpful.

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

Original Message:
Sent: 30-Mar-2021 04:03
From: Monoj Kalita
Subject: EU MDR Label

Hello,


There are companies who provide such translation services, you can outsource this job to them by following your internal procedures. If you are not familiar with any in the US, then you can reach out to your distributor or EU-Rep to find you a suitable one. While outsourcing this job, make sure they have enough experience and expertise in translating medical terminologies.

------------------------------
Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback. 

And to Richard's point about computer screens....Don't forget about "Websites".

This has been a tricky compliance point for many organizations, with divergent country-specific sites, varying levels of change control, differing, layout, content, and links, and less than complete content traceability back to the technical documents.  

Also, Don't forget Annex I 

23.1.   General requirements regarding the information supplied by the manufacturer

Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, 

------------------------------
Michael Chellson
MSc, RAC
------------------------------

Original Message:
Sent: 30-Mar-2021 05:01
From: Richard Vincins
Subject: EU MDR Label

Hello Anon,

Indeed you need to have translation of labelling made for the local language according to the EU MDR.  Keep in mind labelling constitutes many different components like direct device labels, instructions for use, computer screens, user interfaces, etc., so the use of symbols is also quite helpful.

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

Original Message:
Sent: 30-Mar-2021 04:03
From: Monoj Kalita
Subject: EU MDR Label

Hello,


There are companies who provide such translation services, you can outsource this job to them by following your internal procedures. If you are not familiar with any in the US, then you can reach out to your distributor or EU-Rep to find you a suitable one. While outsourcing this job, make sure they have enough experience and expertise in translating medical terminologies.

------------------------------
Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan

Original Message:
Sent: 29-Mar-2021 13:30
From: Anonymous Member
Subject: EU MDR Label

This message was posted by a user wishing to remain anonymous

Hello,

We are a medical device manufacturer located in the US. Recently I took a webinar on the EU MDR, How to create a Label. During this class it stated that the manufacturer had to include the language of the member state where the Medical Device is being sold.

Is this an issue other manufacturers are running into? If it is are you as the manufacturer translating the label or are you leaving this to your Distributor?

Thank you all for you time and I look forward to hearing your feedback.