The EU has placed great emphasis on transparency and accuracy in the MDR. This is to ensure patient rights and a better healthcare system. Hence, there is a need for more detailed descriptions, more languages, and more accessibility to the content.
If all the content required under the MDR is not translated in the languages of the country where the device will be sold, the device will not receive the CE certification. And, you will lose out in that market. That’s how critical translation is.
All medical devices that require the CE certification have to be certified under MDR.
All devices that currently have the CE certification need to be re-certified under MDR. All new devices that require the CE certification too have to be certified under MDR.
So, that means the MDR will touch many medical devices sold in the European Union such as lenses, x-ray machines, pacemakers, breast implants, hip replacements, and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests, and blood sugar monitoring systems for diabetics.
Content types that come into focus for MDR compliance.
Instructions for Use (IFUs)
Summary of Safety and Clinical Performance (SSCP)
The SSCP is another critical document required by the MDR. It includes design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS), and post-market clinical follow-up (PMCF) plans and reports. Content for the SSCP can be primarily derived from the IFU, where applicable. The SSCP of each device will be made publicly available on Eudamed, the European database on medical devices.
Many medical device companies are scrambling to comply. However, as we see it, not all of them are getting the content part right. As a result, their applications often get rejected. They have not only lost time, but also the effort and resources spent on compliance.
Based on our experience of translation in the life sciences field, here are a few quick tips to help with MDR compliance.
The content required under the MDR needs to be translated in the languages of the country where the device will be sold.
The entire IFU along with the updated content, the SSCP, and other technical documentation as required in the Annexes II and III will need to be translated in all the languages of the EU country where the product is to be sold. The information must be accurate and in plain language, to make it accessible to non-medical professionals. That is, any specialized content which may have medical jargon must be put into simpler words.
Any changes made to the device or documentation in one language needs to be reflected in each language the documents are available in. The Notified Body will validate the documents in one language.
For subsequent translations, the company can ensure quality in two ways:
A translation certificate is highly recommended to accompany the translated documentation when applying for certification.
The best practices you adopt to comply with the MDR can come in handy when entering China, too.
Complying with the EU MDR and IVDR can bring additional benefits when you are entering another critical market: China. There are certain similarities in the classifications of medical devices in China.
China too requires manufacturers to translate all labelling and packaging text to Chinese. For Class II and III devices, documentation including product description, intended use, research data, manufacturing information, clinical evaluation data, product risk analysis data, and product technical specifications need to be submitted to the regulating authority.
Working closely with a translation provider is critical to handle the documentation process from beginning to end.
If the language service company is involved from the scratch, it will create the content in plain language and tailored to the health literacy levels of the audience. This not only makes the text simple enough to be understood, but makes translations easier, too.
Multilingual content companies can also advise on the use of technology and handle the project with attention to very small details. Their extensive domain experience and project management skills makes the whole process scalable and produces better quality.
If you are a medtech manufacturer with many product lines, document management becomes an ongoing and full-time task. Each time, there is an update to the product, the content has to be written according to the requirements of MDR and then translated in all the EU languages. You also need to maintain revision history for all the languages.
Clearly, translation is not an add-on task, but a critical business process. Partnering with the right language service company lets you concentrate on your core tasks and makes content management cost-effective.
We welcome the opportunity to work with you and bring your products to the EU market. We offer:
Years of experience working with medical device manufacturers.
Plain language communication to enable clear understanding of the product use instructions.
Use of technology to streamline and expedite the translation process, re-use content, and maintain consistent quality.
Extensive network of veteran linguists in all the major EU languages.
Round-the-clock coverage with offices in Paris, Buenos Aires, and Bangkok.