SBS - The Best Value in QMS software

Providing IFU (Instructions for Use) in multiple languages

#1
I am struggling with the IFU and how to handle this in a practical way.. Currently we have devices containing a IFU / Operation Manual which is 30-40 pages per language.
In order to market the device in all EU Member Status this would end up in a book of 700 pages if we combine it.

Since a device can only be market according the national language determined by member state we have a challenge to include the correct language for the specific country.

our idea is now to import all devices to 1 member state including IFU / Operation Manual for that member state. Importer can verify and device is conform.
For each of the National languages manufacturer will translate the IFU / OM and make this available on website, including article number (UDI with DI and PI for version)
Importer will print a bunch of IFU's - depending on needs and keep them on stock (until he is made aware of change by manufacturer conform contractual agreement).

Whenever importer receives order where he needs to include translated IFU he will do so.

The questions;
1) importer is not translating IFU, does article 16.2 A applies?
1.1) if yes, how do I need to read 16.4 " Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3."
does this means that importer needs to have a QMS certified by Notified Body?

2) can IFU be provided separately from medical device or does it needs to be included?

Many thanks for your help on this! Any other ideas are welcome (e-IFU is not possible..)
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
T Providing Instructions for Use (IFU) vs. 'Help' pages 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
Sidney Vianna Providing confidence to lenders of Renewable Energy projects Sustainability, Green Initiatives and Ecology 0
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
J Extent of 2017/745: providing 3rd party mass produced devices to NHS patients EU Medical Device Regulations 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
Sidney Vianna ISO/TS 17033:2019 Providing confidence in Ethical Claims Other ISO and International Standards and European Regulations 0
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
M Specifications Aerospace - Who is responsible for providing the correct specification(s) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
O ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
M Providing accompanying Medical Device Accessories CE Marking (Conformité Européene) / CB Scheme 2
K Providing Confidence that Quality Requirements will be Fulfilled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S What are the next steps after providing response to FDA 483 ? US Food and Drug Administration (FDA) 7
Ajit Basrur New Guidance - Providing Regulatory Submissions in Electronic Format US Food and Drug Administration (FDA) 1
R Help on providing Pesticide Details US Food and Drug Administration (FDA) 1
B Providing a potential Customer with a Sample Medical Device in Brazil Other Medical Device Regulations World-Wide 1
A Example of Design (Clause 7.3) for Organizations providing Transport Service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
bio_subbu FDA releases draft guidance on Providing Regulatory Submissions in Electronic Format Other US Medical Device Regulations 1
B Calibration Requirements in Organizations Providing Engineering Services General Measurement Device and Calibration Topics 5
M AS9100 Rev C - Determining, Providing and Maintaining" Infrastructure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Providing Evidence of Compliance to MIL-I-45208A and ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Scope Clarification for company providing NDT service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O Simple process for providing Serial/Lot Numbering for our product Document Control Systems, Procedures, Forms and Templates 5
V ESD testers and providing calibration service - 7.6.3.2 External Laboratory IATF 16949 - Automotive Quality Systems Standard 3
M Delayed PPAP - Supplier has delayed providing PPAP for 2 years APQP and PPAP 25
R TS Certification Scope - Semiconductor subcontractor providing assembly and testing IATF 16949 - Automotive Quality Systems Standard 14
Steve Prevette Business Model for Providing Statistical Services Service Industry Specific Topics 5
M Where is (waldo) the customer? Providing consultancy for a "Marketing Company" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Providing A2LA w/ Proficiency Test results General Measurement Device and Calibration Topics 5
B Providing Auditee with Checklist prior to Audit General Auditing Discussions 48
a_bardi FMEA and service providing - FMEA examples in fixed network carriers sector or CATV FMEA and Control Plans 2
T Reliability & Maintainability - No customers providing input into the R&M area Reliability Analysis - Predictions, Testing and Standards 3
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
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
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

Similar threads

Top Bottom