IFU in different language other than English

Harini17

Involved In Discussions
#1
Dear Experts,

I want to understand regarding the language of the IFU. Is it necessary to have IFUs in English language? Per new MDR, Annex II, 2.0; page 117 it states "the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold"

in such instances, what is the approach we need to follow to draft CER and how can we use other language IFU (not in English) as a reference?

Appreciate your guidance.

looking forward to hear from you

Many Thanks in advance!
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hi.. You need to decide which are the member states your product is going into and find out two things from that state.
The language requirement for professional users and the language requirement for the layman.
Depending upon your device and use, you can then decide all the language requirements you need to respect.
When you have your English version of the IFU ready and final, you may approach any qualified professional for needed technical translation and compile a common IFU, as a booklet or multi fold card, having all your languages within and use it with the product. Take all care about the symbols used.
For a start, the attachments may help. Please validate. Good Luck
 

Attachments

Harini17

Involved In Discussions
#3
Dear Somasekar,

Thanks for your valuable guidance. Please correct me if my understanding is wrong :

The other language IFU needs to be first translated to English and approved from qualified professional (such as SMEs, RA) regarding the content and then can be used as a reference in the CER.

Kindly suggest.

Many Thanks!
 

somashekar

Staff member
Super Moderator
#4
Dear Somasekar,

Thanks for your valuable guidance. Please correct me if my understanding is wrong :

The other language IFU needs to be first translated to English and approved from qualified professional (such as SMEs, RA) regarding the content and then can be used as a reference in the CER.

Kindly suggest.

Many Thanks!
No.
I believe that you have first the English language IFU which is correct, complete and approved.
You then use this as input for all other language translations, vide any language experts for technical literature translation.
You maintain the credentials of the translator to support your translation correctness.
Its very important that you select here such competent translators and such companies who offer these languages services
(I do not get what you mean by CER)
 

Harini17

Involved In Discussions
#5
Dear Somasekar,

Thank you for your suggestion. CER - clinical evaluation report, for marketing any medical device in the Europe Union (CE mark approval), it's mandatory to have Clinical Evaluation report and the IFU is one of the source docs used as a reference in drafting the CER.

Thank you!
 

QM_123

Starting to get Involved
#6
Dear Experts,

I want to understand regarding the language of the IFU. Is it necessary to have IFUs in English language? Per new MDR, Annex II, 2.0; page 117 it states "the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold"

in such instances, what is the approach we need to follow to draft CER and how can we use other language IFU (not in English) as a reference?

Appreciate your guidance.

looking forward to hear from you

Many Thanks in advance!
Hello Harini,

I think English is not necessary, because as you quoted, you must use the language which is accepted in EU member states. However, you must take into account some parameters; first of all your NB's language, i.e if you a French company but your NB is Hungarian so your IFU should be English because most probably your mutual language will be English. On the other hand you have to think about your competent authority, most probably it will demand your official language version. And finally, you have to think about your customers. You know, IFU is important document to properly inform users, therefore it should be understandable totally for users and so IFU should be prepared according to user profile, so if you are a exporter please consider your customers language.

Regarding your question on CER; actually you know whole technical file documents should be prepare same version; I mean language of whole file must be same . But, as Somashekar says, your all versions must be same (word for word). Generally manufacturers prepare IFU as one document which includes all language versions, I suggest you to prepare by this method and finally it will not be important which version is referenced for your IFU, because finally it will include all languages. Please be sure all language versions (translations) are same and again as Somasheakar says it must be translated by a really experienced interpreter who can make technically correct translation. I hope this will be helpful, I know lots of companies all follow this method and until now everything is OK.
 
Thread starter Similar threads Forum Replies Date
M Is there a way to obtain redacted copies of IFU from a different manufacturer? EU Medical Device Regulations 2
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
C CE Mark of a purchased Medical Device with different IFU EU Medical Device Regulations 7
D Labelling and IFU deadlines EU Medical Device Regulations 3
M Addition of IFU on local language by distributor - Article 16? EU Medical Device Regulations 1
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
J EU 207/2012 E-IFU Service Video EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
K No IFU, where the requirements would go? EU Medical Device Regulations 5
P IFU Translation Requirements for EU EU Medical Device Regulations 2
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
K REF symbol with product code in the IFU EU Medical Device Regulations 1
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 1
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
K Label - IFU requirement, maybe? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Electrosurgical devices/surgery IFU contraindications EU Medical Device Regulations 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur Incoming Inspection for Instructions for Use (IFU) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
D 207/2012 Update for MDR (?) - Instructions for Use (IFU) EU Medical Device Regulations 9
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
P IFU for Sterling Silver Surgical devices ISO 13485:2016 - Medical Device Quality Management Systems 3
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
E Does posting your IFU on your website constitute elabelling? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Is Notified Body approval necessary for small changes to IVD IFU? CE Marking (Conformité Européene) / CB Scheme 7
M Laminating abbreviated Operators Manual to IFU's and DFU's ISO 13485:2016 - Medical Device Quality Management Systems 1
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
E IFU Changes - How it is ensured that IFU changes reach Surgeons EU Medical Device Regulations 4
J Canada Bulk Packaging and IFU requirements for Class IIa and IIb Medical Devices Canada Medical Device Regulations 2
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom