The Medical Device Regulation will require all medical device content to be translated into the language of each member state.
It is important to note that the definition of medical device is also expanding to include such products as breast implants and coloured contact lenses. MDR have said a medical device constitutes as ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used alone or in combination for human beings.’
MDR have widened the definition of medical device and brought in this new regulation in order to create more transparency. The aim is to make the purchasing and usage of medical devices easier and better for all those involved from purchase through to end user.
Unique Device Identifier (UDI)
As part of the new regulations all medical devices are expected to have an UDI. This UDI includes a Device Identifier (DI) and a Product Identifier (PI).
A Device Identifier works as a link between the manufacturer and the device. A Product Identifier is for identifying the unit of device production.
The UDI for all medical devices will be included in the EUDAMED (European Database on Medical Devices) database. Therefore, as part of the MDR regulations the UDI needs to be available in all the languages of member states.
Instructions for Use (IFUs) will also be included in the EUDAMED database and need to fulfil the same translation requirements. All aspects of the MDR regulations need to be available in the official language where the product will be sold.
Furthermore, the MDR states that the language must be understandable to all. So, it is important to avoid heavy jargon in order to make all aspects that require translation comprehensive to readers at all levels.
How MDR affects translations
Of course, translation has always played apart in the medical industry throughout the EU, the difference with the MDR regulation is that translation is now mandatory from 2020. Moreover, the responsibility of translating the content falls onto the manufacturers instead of the member states.
This means that manufactures must translate their content into all 24 languages. All content has to be available in all 24 even if manufacturers currently translate into a few they will have to increase to the required amount.
Previously translations would not be required before CE marking, however this is also looking to change. As CE markings indicate that medical devices conform with the requirements of the EU, the new MDR regulation comes as a part of this. Therefore, the translation of all content including, UDIs and IFUs need to be translated before CE marking.
Manufacturers of devices such as cosmetic surgery products and medical software will now have to consider translation whereas they previously may not have. Furthermore, manufacturers need to consider trained and professional translators in order to make sure that their content is translated to the EU MDR standards.
As mentioned, all the information on medical devices will be stored in the EUDAMED database. In all 24 languages. This means when using a translation service, manufacturers will need to be conscious that a translation company can trace their work throughout new product launches and update existing ones. It is very important that the EUDAMED database is kept as up to date as possible.
Why use a professional translation service?
One of the main reasons behind the new MDR regulation is to make the world of medical devices easier of all. Therefore, the advantage of using a new a professional translation service is consistent high quality and accurate translations.
DA Languages has nearly 20 years’ experience working with the medical industry. This means we understand the language that of medical suppliers and manufacturers. Our dedicated translation team are skilled in medical translation and will be able to make all medical device content understandable to all those who will interact with your medical devices.
Through using DA Languages, you’ll receive a high quality and dedicated service to make sure that your ready for the MDR deadline! And that you can then provide a better service to your clients and future users of your medical devices!