Language Translation Requirements for Software Interface in EU Countries

J

Jwreeves

#11
esalsan, thank you for the additional input.

I did receive input from Swissmedic this morning. See below.

Abstract from the Medical Devices Ordinance:
Article 7 Product information
1 Product information shall be in accordance with:
a. Classical medical devices: Annex I, Section 13 of the Directive 93/42/EEC43; b. Active implantable medical devices: Annex 1, Sections 14 and 15 of the Directive 90/385/EEC44; c. Medical devices for in vitro diagnosis: Annex I, Section 8 of the Directive 98/79/EC45.46

2 The product information must be written in all three official languages. Symbols which are contained in harmonized standards can replace wording.

3 Product information can be restricted to less than the three official languages, or be in English,
provided:
a.47 the medical device is supplied exclusively to professionals or where the medic al device is a custom-made device or a medical device manufactured in-house; b. there is assurance that the user has the necessary professional and linguistic qualifications, and agrees with the language restriction; c. the protection of patients, users and third parties is nevertheless ensured; and d. effective and intended use is not jeopardized.

4 If requested, additional information shall be given to users in one of the official languages.

5 If a product that is not, or not yet, permitted to be placed on the market as a medical device can be confused with one that is, the clames of the former must clearly and legibly indicate that it is not a medical device and is not suitable for medical purposes.

For the software interface are the same rules applicable


Swissmedic does give exemption for professional use in Rule 3. However it is followed up by additional risk concerns and then Rule 4 requiring languages to be supplied when requested.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Language Translation Requirements for IVD's on the EU Market ISO 13485:2016 - Medical Device Quality Management Systems 3
P Medical Device Language Translation Requirements EU Medical Device Regulations 9
C Class II Medical Devices - EMC Table - Language Translation Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
D Language Translation Requirements - Medical software company ISO 13485:2016 - Medical Device Quality Management Systems 3
J Malaysia - Full Labelling Local Language Translation Other Medical Device Regulations World-Wide 1
E Addition of French Language (translation) - New 510(k) required? Other US Medical Device Regulations 1
C Translation Of Foreign Language Standards Various Other Specifications, Standards, and related Requirements 6
J Language localization and translation services - Finding of nonconformity or not? Nonconformance and Corrective Action 5
Jim Wynne Lost in Translation - Computer translations of one language to another After Work and Weekend Discussion Topics 2
M Spanish Notified Body - Spanish language CE Marking (Conformité Européene) / CB Scheme 2
R Language translator Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
C Language of SOPs and SOP IDs Document Control Systems, Procedures, Forms and Templates 7
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
Ronen E The unbearable insensitivity of risk management language Other Medical Device and Orthopedic Related Topics 1
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
H IFU in different language other than English EU Medical Device Regulations 5
T MSDS Language Requirements for Reach Purposes REACH and RoHS Conversations 3
A PFMEA English language question IATF 16949 - Automotive Quality Systems Standard 4
M Is it ok to provide a different language upon request? EU Medical Device Regulations 25
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
F EU Language Requirements : Medical Devices/IVDs EU Medical Device Regulations 1
S Language of procedures when operating in multiple countries ISO 13485:2016 - Medical Device Quality Management Systems 4
O Definition Korean Definitions - Korean Language Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
L Canada Electrical Equipment Marking Language Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Taking exception to REACH Requirement - Appropriate Language REACH and RoHS Conversations 4
Marc Definition UBL - Universal Business Language Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M PPAP Language for Purchase Order APQP and PPAP 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
B PFMEA, Internal Auditing, Corrective Action Training In Native Language (China) Training - Internal, External, Online and Distance Learning 1
V Language is not a barrier if you know the "thing/subject" and "art of communicating" Coffee Break and Water Cooler Discussions 8
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
Marc Polish Language Quality and Standards Forum Book, Video, Blog and Web Site Reviews and Recommendations 0
DanteCaspian Free Poster Download: LANGUAGE OF LEAN CULTURE (2017 Revision Attached) Lean in Manufacturing and Service Industries 14
K Evidence for Language Knowledge of Employees Professional Certifications and Degrees 9
S Medical Device Registration Language Requirements in Portugal EU Medical Device Regulations 4
S Chinese / English Language REACH Statements RoHS, REACH, ELV, IMDS and Restricted Substances 4
AnaMariaVR2 Finding a Common Language for Disaster-resistant Supply Chains Supply Chain Security Management Systems 1
C IFU Language Requirements for FDA Clinical Study conducted in EU EU Medical Device Regulations 3
D Labeling language regulation China vs. CE/MDD EU Medical Device Regulations 12
Marc How is Happy Birthday written in your language? Coffee Break and Water Cooler Discussions 24
C Creating a Multiple Table SQL (Structured Query Language) Query in Minitab Using Minitab Software 10
L Free Sale Certificate (FSC) in different language for Thailand Other Medical Device Regulations World-Wide 2
G Multi Language Instructions - Standard for Type Size when Printing Instructions? Other ISO and International Standards and European Regulations 2
somashekar The Beauty and Complexity of English Language Funny Stuff - Jokes and Humour 1
H List of Language requirements for Jordan, Iraq, Libya, Oman, Lebanon, UAE, Yemen, Sau Other Medical Device Regulations World-Wide 7
somashekar Language and Communication Imported Legacy Blogs 2
N English as a Second Language - English problems with Legal Terms Contract Review Process 2
B Language Requirements - Labels/IFU (Professional Use Medical Devices) in Bangladesh Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom