Regulatory Open Forum

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

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PASCALE
France
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This message was posted by a user wishing to remain anonymous

Hi Pascale,

Many software developers have this question indeed.
As you may know, the IVDD suggests and the IVDR requires to provide the information (set out in Annex I, Part B, Section 8 IVDD or Section 20 of Annex I IVDR) in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. An overview of these official language(s) per country can be found here:
European Languages by Countries :: :: Official and national Languages of Europe - Nations Online Project

In case of software as an (in-vitro diagnostic) medical device, this requirement must also be followed, as it can make the same product available in multiple member states.

Hope this answers your question.
Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------

Dear Anonymous,

Thanks a lot for your answer
Have a nice week

Pascale

------------------------------
PASCALE
France
------------------------------

Original Message:
Sent: 23-May-2021 13:04
From: Anonymous Member
Subject: European Regulations and language for software and instructions

This message was posted by a user wishing to remain anonymous

Hi Pascale,

Many software developers have this question indeed.
As you may know, the IVDD suggests and the IVDR requires to provide the information (set out in Annex I, Part B, Section 8 IVDD or Section 20 of Annex I IVDR) in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. An overview of these official language(s) per country can be found here:
European Languages by Countries :: :: Official and national Languages of Europe - Nations Online Project

In case of software as an (in-vitro diagnostic) medical device, this requirement must also be followed, as it can make the same product available in multiple member states.

Hope this answers your question.
Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------

This message was posted by a user wishing to remain anonymous

In this webinar / virtual conference presentation, Monir El Azzouzi spoke about creating a medical device label, and in it, he touched on languages. I don't think it completely answers your question, but it might point you in the right direction or perhaps consider reach out to him:

https://mdr.greenlight.guru/talks/how-to-create-medical-device-labels-per-eu-mdr/
Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------

Hi Pascale, I believe that MedTech Europe has such a list but this is members only content. RAPS could perhaps crowdsource a similar list? You would need a layered list for that:

• Default language requirements for devices
• Exemptions for certain device (e.g. software) and conditions for exemption (e.g. option to acquire IFU in original language anyway)
• Exemptions for certain users (e.g. professional users) and conditions for exemption (e.g. in the Netherlands a manufacturer can label in English for professional users but must track in PMS if the users actually understand the label and IFU).
• Other relevant language legislation like workplace legislation (I vividly remember a client getting in trouble with a French hospital with a piece of expensive capital equipment with its own GUI in English because of French workplace legisation that entitles staff to a French language only working enivronment and certain staff refusing to use the device).

Best regards,
Erik

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------

Dear Pascale, 

in addition to the anon-post, you may consider the "old" list from Team NB (The European Association Medical devices of Notified Bodies) called: Mandatory Languages Requirements for Medical Devices. This list was in the www as being subject to the MDD, nevertheless it is a valuable source for me. 

You will find the PDF here.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
------------------------------

Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------

Dear Uwe

Many thanks

Pascale

------------------------------
PASCALE
France
------------------------------

Original Message:
Sent: 25-May-2021 09:13
From: Uwe Zeller
Subject: European Regulations and language for software and instructions

Dear Pascale,

in addition to the anon-post, you may consider the "old" list from Team NB (The European Association Medical devices of Notified Bodies) called: Mandatory Languages Requirements for Medical Devices. This list was in the www as being subject to the MDD, nevertheless it is a valuable source for me. 

You will find the PDF here.

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany

Original Message:
Sent: 23-May-2021 07:03
From: PASCALE BLANGARIN
Subject: European Regulations and language for software and instructions

Dear all,

I am frequently asked the question about the language requirements for package inserts and user manuals but also for software (human-machine interface) of in vitro diagnostic medical devices in Europe, and for some European countries it always proves to be quite complex to answer especially for the software and I was wondering if there is somewhere an overview of these language requirements for each country, according to Directive 98/79/EC and Regulation 2017/746.

Many thanks for your answers

Pascale

------------------------------
PASCALE
France
------------------------------