The new European Union Medical Device Regulation (EU MDR) came into force in 2017, and following a three year transition period, all these requirements are to be officially implemented from 26 May 2020. All medical device manufacturers selling products in the EU must prepare to meet the terms of this regulation by the deadline.
While there are many new guidelines manufacturers must now follow before they can get their medical devices onto the market, it’s interesting that many parts of the regulation directly relate to the translation process. There has always been an emphasis on translation given that one EU-approved device could be used by numerous medical professionals, all speaking different languages. However, its importance is now even greater under the EU MDR, as translation will play a pivotal role when it comes to regulatory compliance.
How is a medical device defined?
According to the EU MDR, a medical device can be defined 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”. Such items can be used to diagnose diseases, injuries and disabilities, investigate and modify parts of the anatomy, and provide information following in vitro examination of a specimen derived from the body. Examples of medical devices include dental and surgical instruments, bandages, splints and even hospital beds.
What does the EU Medical Device Regulation mean for manufacturers?
The EU MDR replaced the Medical Device Directive (MDD) to improve the standards of such devices, and also increase the accuracy and detail of any labels and additional information.
Under the new regulation, there are technically more medical devices than ever before. This is because, as listed under Annex XVI, there are now many products that must comply with the new regulations even though they don’t have intended medical purposes. Examples of these devices include non-prescription coloured contact lenses, dermal fillers and equipment used for cosmetic procedures like liposuction.
Medical device manufacturers need to make sure their products comply with the EU MDR by carrying out a conformity assessment. These are performed by notified bodies, whose activities include calibration, certification, inspection and testing. If the device passes the assessment, it receives a CE mark to show that it meets all the EU’s requirements. This process applies to medical devices already on the market, as well as any new ones.
Though devices can currently be placed on the market under the current Medical Device Directives, anything following the end of the transition period must comply with the EU MDR. However, a manufacturer may take advantage of the extended period of CE validity instead, which means that any certificate granted under the MDD within the transition period is valid for four years after the date of issue.
If you are currently manufacturing a medical device, click here to learn more about the legal requirements.
How does the EU MDR affect the translation process?
Translations have always been important in the medical device industry as these ensure that people are able to identify and use a product no matter what language they speak. If someone misunderstands the translation, they could end up breaking or misusing the device, which would potentially be very dangerous for the patient. This is why every word must be entirely accurate and appropriate for the medical device’s intended user.
However, under the new EU MDR, translations are now even more important than they were before. Now, rather than relying on the EU member states for these, manufacturers will be responsible for acquiring them themselves. The following points apply when it comes to the language of medical devices as part of the regulation:
Translations are required in all 24 EU languages
While individual states previously chose their own selection of languages, the new EU MDR stipulates that medical device content must be available in all 24 official EU languages. Therefore, if you currently only translate into a fraction of these, you’ll now be required to increase this to meet the needs of all EU members.
Some translations are required prior to CE marking
Translations were typically required after a medical device received the CE marking, but now translations of documents like Instructions for Use (IFUs) must be submitted as part of the technical dossier required by the notified bodies for conformity assessment. In order to meet the new requirements, the translation will now come earlier in the workflow.
All translations must be precise and clear
The medical device’s end-user must be able to easily understand all the language of medical device content, including IFUs, labelling and safety information. This applies to the original source language as well as the translated material. As a result, translators will be trained and monitored appropriately in order to make sure all content complies with the EU’s demands.
Translated data will be stored in a European database
All medical device information will be stored in a central European database called EUDAMED, ensuring that data in all applicable languages can be logged and exchanged. Therefore, your language service provider will need to use client-based Content Management Systems and have its own Translation Management System. This allows for consistent translations and means their work can be traced.
How can a translation agency help you prepare for the EU MDR?
These regulations require manufacturers to continuously work with their translators in order for the medical device to pass its conformity assessment and receive its CE marking. Here at London Translations, we offer a team of professional and experienced medical device translators who fully understand the strict terms of the EU MDR. With a Quality Policy in line with ISO requirements, we can guarantee that all the revisions made to your medical device documentation will be accurate and meet all the legal requirements for your EU markets. Contact us today to find out how we can help you.