Hello Evangelos,
You have a few questions there, so will have to be short on the responses for each of them.
1. There are some methodologies which are commonly used, such as independent verification, second-eyes, back-translation - the important aspect is having a procedure defining how this is done. You can also refer to ISO 17100 as you mention later.
2. No, this would be up to own controls and requirements. It would be recommended to look at certification as gives another level of assurance an entity is reviewing the quality system.
3. Yes, that would be advisable but not necessarily always required. Definitely in medical devices, but a specific device type - this could be addressed through say back-translation making sure the technical terms or phrases are clearly understood.
4. The translation company should be on the Approved Supplier List (ASL), yes. As a crucial/critical supplier? Maybe. Using a risk-based approach for supplier qualification would need to determine the level of risk with the translation. For lower risk, professional use devices, with "less" words in the IFU maybe not a high level of risk, but an lay-person/Over the Counter (OTC) more complicated device, probably a higher risk.
5. Yes, though this does not need to be internally. As mentioned in the methodology there are different verifications which can be used, but I would recommend having one. Many companies just translate, and then find issues later one because the translation was not checked or verified.
6. Yes :).
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 15-Dec-2021 05:26
From: Evangelos Tavandzis
Subject: translation requirements, specifically translations of instructions for use /IFU/ and descriptions on labels provided by an external source
Hello RAPS members.
My question concerns translation requirements, specifically translations of instructions for use /IFU/ and descriptions on labels provided by an external source to various countries, both the EU and others.
Q:
- Are there MDCGs or other documents that describe the translation methodology? specifically according to MDR?
unfortunately I did not find any
- it is legislatively described that the external company should have a certificate acc. To EN ISO 13485: 2016 and ISO 17100: 2015 for translations in the medical devices sector or it can be determined by the manufacturer according to its internal regulations?
- such an external firm should have competences not only in the field of medica devices but in a narrower sector / group such as beds or x-ray devices,…. and demonstrate its competence in addition to the certificate, for example by experience in this narrower sector,
- an expert in this field (eg doctor, bioengineer, ..), - knowledge of standards such as EN 20417, EN ISO 15223-1: 2021 and - specific standards in the narrower sector?
in my opinion yes
- this external translation company should be classified and evaluated as a critical contractor with the possibility to carry out on-site / on-line supplier audits?
in my opinion yes
- the producer should then verify and / or validate such a translation (eg IFU) internally in terms of content, expertise and grammar according to the internal translation procedure?
in my opinion yes
6.A contract should be concluded between the manufacturer and the translation company?
in my opinion yes
If you have experience in this area, I will ask you to share your experience on these issues
I'm sorry for my English, it's not as good as I would like it to be
------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------