October 2021.
The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle.
The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the device through the information available with the product.
This is achieved by making sure that the information is accessible through Official languages of the EU member states.
In this article OMC brings to your attention on the documents that are required to be translated and how this can be achieved and what measure that MDR has in store to verify the compliance of the manufacturers.
EU MDR – Language Requirements
In Article 10 General Obligations of EU MDR 2017/745 states that the manufacturer should make the product information available in one or more Official languages of the member states where the product is put in place for use.
The main goal about linguistic requirement is not to make complex process for the manufacturers but for the users to understand the product without any difficulty so make it available in Official languages ensures this aspect.
The Annex 1 specifies all information provided should follow the Internationally recognized symbols and identification colour. This should be conforming to the harmonized standards of ISO 15223-1:2016* and the New ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer
What is the Information covered by MDR language requirements?
In general terms the most commonly required information is the product information – Labelling, packaging and Information for use (IFU) in some cases User manual, but it’s not limited to only the product information but to other information such as the product safety documentation related to the user, Implant cards (Patient card) these are also covered by the language requirements.
Information for Use
The information that elaborates the usage of the product by step-by-step instructions or by explains the user how to use the product and its full functionality is commonly referred as the information for use (IFU) or the User Manual (UM).
This information is required to be available in the Official languages of the Member states where the product is sold.
This can be available either by electronic version nor printed version as per the requirement of the Economic operator or the user. The electronic version is covered by the EU regulation No.207/2012. This is commonly called as the eIFU or electronic IFU.
The electronic version can be available at the request or available online on the manufacturer/Economic operators website for ease of access to the user, this information should be mentioned in the product information that is shipped along with the product.
Graphical user interface for medical device software
The standalone software and apps or medical device products which has an User Interface (GUI) is also considered as a Information for use as per the EU MDR guidelines.
This is also required to have multiple language options for users to select or at least the user manual to use them should be available in Official Languages by EU Member States where the product is sold.
Marketing materials
The marketing materials are also considered as the information for use as it provides the intended use of the device, however in deeper understanding a marketing material is considered as the Labelling or product information that accompanies the product.
Labelling
Based on EU MDR there are different levels of labelling.
- Primary Label,
- Secondary Label
- Transportation Label.
These labels are to be translated into different languages as well. Most manufacturers are currently shipping products with the international standard of English as the main label on the packaging.
However, it is required to have the labels if Customs official request these you should be able to send it through your Economic operators.
However, there is a lot of confusion on what is required to be translated in labelling, previously in EU MDD there was no clear information on what needs to be translated so manufactured everything in the label expect for the Trade name.
In MDR it clearly states that the short device description should be translated into multiple languages
Eg:
- EN Medical Device Description
- FR Description du dispositif médical
- DE Beschreibung des Medizinprodukts
Other than the product information below information should also be available upon request by either the user or the authorities (CA – competent authorities according to EU MDR)
EU Declaration of Conformity (DoC)
The DoC is a main document ensuring compliance by the manufacturer this document is mostly only available in English however it is required by EU MDR Article 19 that the document is available in the Official languages of Union Member States.
Certificate of Conformity
The Certificate of Conformity it would be the CE certificate, ISO certificates of the manufacturer these are also required to available by EU MDR Article 56 that the document is available in the Official languages of Union Member States.
Field Safety corrective actions (FSCA)
In cases where corrective and preventive actions are taken, they are also to be available in EU MDR Article 89 that the document is available in the Official languages of Union Member States.
How EU MDR ensures these are followed:
The EU MDR regulation requires the Economic Operators especially distributors and Importers to verify the language requirements of the users they sell to and ensure these languages are available through the manufacturer and are required to maintain a copy of the above information in their Quality management system (QMS).
How can we support you to achieve this?
OMC as an ISO accredited Translation agency have a network of Linguists to support multiple languages across the globe. We cover all the 24 Official languages of European Union and can support you with quick Turn arounds depending on the size of the project.
Though we offer the translation service as a secondary service, OMC medical have team of members who will run your project for you by ensuring the quality of work on the translations.
Depending on your requirement and budget we can work out a cost-effective solution to support you with this huge task.
Our team of Linguists have expertise in the field of translations and medical background to ensure the technical terminology nor the instructions clear and clear for the user. We have a multi-level verification process to ensure the quality of the documentation is maintained.
Please enquire for more information at regulatory@omcmedical.co.uk or contact us via (contact us page link). You can also use the online quote form (quote page link) to get an official quote
*ISO 15223-1:2016 3rd edition is superseded by the new standard published this year ISO 15223-1:2021 4th Edition, however this is currently on the transition period until March 2022. So please make sure you are adhering to the latest version if you are in progress of Label remediation according to the new EU MDR 2017:745 regulation.
