Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do?

Darshan_Shetty

Starting to get Involved
#1
Italy, Germany, Spain, Netherlands, France, Switzerland, Austria, Romania, Poland, Belgium, Denmark, Sweden, Czech Republic.

I know countries are stricter in Labels that go on the device and require it to be in national language but User Manuals are usually allowed to be in English in many countries. I was hoping that folks here have some experience dealing with this issue and could point me to the national regulations that state translation is mandatory.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Darshan,
You can search for the English translation of each of the national medical device law (e.g. The German act is called Medizinproduktegesetz – MPG) but it would be much easier to contact your local EU Rep. and ask them for a language localisation table.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Officially, user manuals (=IFU) are labelling. The regulations require that labelling is provided in each Member State in one of the languages officially recognised by that State. Some recognise English and some don't.

Whether this dry requirement is enforced (more or less strictly) in a given State is a separate matter. Hint: Member States are generally low on resources for enforcement where the perceived risks are not high. Mind you, the competition may whistle-blow for commercial gain, in which case the regulators are theoretically obliged to respond (albeit reluctantly / sloppily).
 

Darshan_Shetty

Starting to get Involved
#5
Officially, user manuals (=IFU) are labelling. The regulations require that labelling is provided in each Member State in one of the languages officially recognised by that State. Some recognise English and some don't.

Whether this dry requirement is enforced (more or less strictly) in a given State is a separate matter. Hint: Member States are generally low on resources for enforcement where the perceived risks are not high. Mind you, the competition may whistle-blow for commercial gain, in which case the regulators are theoretically obliged to respond (albeit reluctantly / sloppily).
Wow.. that is interesting. Did this whistle blowing thing happen to someone around you ? Just curious.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Wow.. that is interesting. Did this whistle blowing thing happen to someone around you ? Just curious.
I was once indirectly involved as a consultant, on the whistle-blowing side. I pretty much watched from the sidelines (a lawyer handled it) and got a pretty good look of how the regulators handled it.
 
Last edited:

Asia78

Involved In Discussions
#8
We have always requests from our distributors in Italy and Spain about manual and product label in Italian and Spanish.
Italian authorities are also often checking randomly the repertorio database and may ask for addiitonal info in italian.
And some years ago we got a minor non conformity by our NB because we gave to customer in Sweden the user guide in English only...
 

Nigel-S

Starting to get Involved
#9
I have a similar situation regarding user manuals and would like to run it by you guys.
We are a Class 1 (not 1R,1S,1M) Pilates health exercise equipment manufacturer, located outside the EU and selling product to rehabilitation and physiotherapy clinics across nearly all of Europe (25 countries). Our equipment ships with the Owners Manual written in English only. We also ship with each product a user instructional DVD in English but has language tracks on it for English, French, Spanish, Portuguese, Italian and German.
Would I need to have the Owners Manual translated into every language?
Would it be acceptable to ship the product with the English Owners Manual and have a link stated in the manual to the company website where a translated version of the Owners Manual could be downloaded?
Would the instructional DVD have to be translated for all 25 countries that we sell into?
Cheers, Nigel.
 
Thread starter Similar threads Forum Replies Date
Q European Translation Requirements - English to German - Medical Device User Manuals EU Medical Device Regulations 9
M Digital user manuals CE Marking (Conformité Européene) / CB Scheme 0
P Datron/Wavetek 4808 Option 70 Wideband Source - User and Service Manuals needed General Measurement Device and Calibration Topics 2
R EU-countries which don't accept English user manuals and require national translation CE Marking (Conformité Européene) / CB Scheme 9
Wayne User's Manuals for Variable Screw Thread Measurement Systems General Measurement Device and Calibration Topics 1
K Labeling Requirements for Software - No User Manuals? Other US Medical Device Regulations 1
Y User Manuals for Radiation-Emitting Electronic Products US Food and Drug Administration (FDA) 0
T Documenting hazardous situations associated with user/patient population ISO 14971 - Medical Device Risk Management 3
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
S Recommendation for user friendly Gaga R&R and Cpk software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 1
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
A Cassette Representation - GUI (Graphical User Interface) on my medical device - A mammography Device Other Medical Device Related Standards 0
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 6
M Informational US FDA Medical Device User Fee Rates for Fiscal Year 2020 Medical Device and FDA Regulations and Standards News 0
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
G Posting Measuring Equipment Accuracy for User Information General Measurement Device and Calibration Topics 4
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
Ed Panek Splitting UI (User Interface) into two development paths 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Publication of user information in manufacturer website for medical devices Other Medical Device Regulations World-Wide 2
Ed Panek User Feedback both negative and positive and acting upon those metrics 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
Marc Search - Search for Discussion Threads started by a specific User Elsmar Xenforo Forum Software Instructions and Help 0
Marc Search for Posts - By specific User Name(s) Elsmar Xenforo Forum Software Instructions and Help 1
Marc User Agents of Forum Visitors - 6 November 2018 Forum News and General Information 0
Marc User Post Counts - 20181101 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
Marc Forum User Name - I Want to Change my Forum User Name Elsmar Xenforo Forum Software Instructions and Help 0
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1
shrutisancheti EU User manual / operator manual / service manual guidance document(s) CE Marking (Conformité Européene) / CB Scheme 2
D How to deal with user needs when it is obvious the design meets the user need 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
shrutisancheti Upgrading medical device at healthcare establishments (user facility) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Definition User Needs - Concrete definition for "User Needs" as required by the FDA Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
M User Errors and Product Nonconformances Nonconformance and Corrective Action 22
G Design and development of user centric audit report visualisation tool Design and Development of Products and Processes 5
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 7
J TOPCON PP-70 Optical Comparator - User Manual Needed General Measurement Device and Calibration Topics 0
J Who is the Customer - Who is the End User Manufacturing and Related Processes 2
S Trying to understand 7.2.1(d) of ISO 13485 - Medical Device User Training ISO 13485:2016 - Medical Device Quality Management Systems 8
JoCam User Manual Release before CE Mark EU Medical Device Regulations 5

Similar threads

Top Bottom