IVDR Language Requirements
The diverse range of live European languages presents a few challenges in determining which languages are required, for translation of your IVD’s product literature.
The update to the EU IVD regulatory framework presents clarity on this, as they are only minimally discussed in the text of the IVD Directive 98/79/EC.
So, what changes in IVDR language requirements will we see, moving forward?
One key change is the emphasis of the instruction within the current IVDR; the active voice replacing the prior passive instructions, to be found in the IVDD. For example, now; “Manufacturers shall ensure…” instead of “Member States may require…”.
Article 10 – General obligations of manufacturers
In Articles 10(10) and similarly in 10(13) the following phrase is used:
..in an official Union language(s) determined by the Member State in which the device is made available.
For manufacturers, 10(10) (also stated in Annex II) means that the information which is supplied to the end user will need to be translated into a language suitable for them. This presents two challenges:
- Which languages are required?
Based upon the information in the public domain, this can often be difficult to determine as published tables seem to contain subtle differences, creating ambiguity. So, if there is any doubt, then the best option is to consult the competent authority from the member states that you wish to make your product available in, for their specific guidance.
- Quality & accuracy of translation
The Information that is supplied with the device is extremely important as in the case of the IFU, this instructs the end user how the device is to be used safely, and under which circumstances it must not be used. Therefore, it is a key part of the device and any translated material must be as accurate as possible. Google translate can be useful, but could not be responsibly used independently for medical device translations. Instead, manufacturers should source an accredited translation company, with access to translators with experience in a scientific discipline, appropriate to medical devices. Treat your translation provider as a supplier and qualify them as suitable, as part of your internal supplier process, using a risk-based approach.
Furthermore, Annex I (20.1) also requires that the information accompanying the device is to be made available via the manufacturer’s website. In multiple languages, where appropriate.
Article 10(13) would suggest that there is the possibility that other documentation, e.g. technical documentation, may need to be provided upon request from a competent authority, in whichever language determined by the Member State concerned.
Article 11 – Authorised representative
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
This article indicates EU authorised representatives need to be prepared for translation arrangements with the manufacturer.
Article 17 – EU declaration of conformity
17(1) …The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
So this needs also to be factored into your translation strategy, once the member statement requirements are understood. Think about how your organisation will ensure this carried out?
Article 84 – Analysis of serious incidents and field safety corrective actions
84(8) …The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
So this means that, If you haven’t already done so, you need to revise your internal QMS procedures to ensure that this requirement will be fulfilled when needed.
How IMed Can Help
The language issue for your IVD may not be particularly onerous, but it is nonetheless important. IMed’s IVD team have first-hand experience in this area and are equipped to identify the required tweaks to procedures and control mechanisms and to facilitate collaboration between marketing and project management teams to ensure translation costs are considered within budget.
If you need guidance or analysis on translation needs, or have any IVD related queries, please get in touch with us.
IMed QA & IVDR Consultant