Regulation (EU) 2017/745 on Medical Devices (MDR) and Translation

Ciklopea 4 months ago Comment

On 26 May 2021, EU Medical Device Regulation (MDR) replaced the EU’s current Medical Device Directives and while the medical devices manufacturers have largely ensured compliance with the new regulation, this change will have an impact on development of documentation related to the medical devices, translation and regulatory cycles in the EU.

In this article, we take a look at the impact of MDR on professional translation for the life sciences sector.

More Product-Related Documentation

The MDR classification of medical devices has been extended to include more medicinal products, meaning that more products might be classified as medical devices than before. In addition, medical devices manufacturers are also responsible for devices once they are marketed and for the technical documentation, and there are new and more precise requirements for clinical trials to be conducted by the medical devices manufacturers.

The new guidelines also require more detailed labeling, description of the product, clinical data, documentation, software and information about application of the device, “clearly comprehensible to the intended user”.

In other words, more IFUs will need to be translated and submitted for approval to healthcare authorities for every market.

Mixed Complexity Levels

One of the particularly interesting changes related to translation refers to the manufacturer‘s responsibility to draw up the Summary of Safety and Clinical Performance in a form that intended users and patients can understand.

This means that it might be necessary to develop and translate information intended for the healthcare professionals and patients in the same document.

Focus on the User

Many of the changes required by the MDR compliance relate to the availability and clarity of the product-related documentation to the users of medical devices.

For example, the IFUs must be available on the manufacturer‘s website, linked to the Summary of Safety and Clinical Performance (SSCP) (written in or translated to the language understandable by the user) and uploaded to the EUDAMED database, and to quote from the MDR itself:

  • IFUs “shall be written in terms readily understood by the intended user, and, where appropriate, supplemented with drawings and diagrams”
  • SSCP must be submitted for class III and implantable devices in a language “easily understandable to the intended user”
  • Labeling must be “clearly comprehensible to the intended user”
  • Information supplied with the medical devices must be “easily understandable to the user”

This all means that there will be more demand for translation of patient-facing content and that having a reliable provider of language services with the appropriate experience and expertise in content production and  development of translation solutions for the medical devices sector will remain to be crucial for smooth operation and closing of regulatory cycles on the European market, and one of the reasons for this is that manufacturers now also need to provide documentation in English and in their language.

Last, but not the least, centralized management of translation services for the official languages of the EU is probably the best model for  the manufacturers of MDR-compliant medical devices because this model enables uniform execution of the translation process and the quality control across the language pairs.

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