Translations for medical devices
What is the role of translation in the field of medical devices?
In recent years, new European directives have brought fundamental changes to the medical devices sector, including the recent MDR 2017/745: which includes the extension of the field of application, the clinical evidence required for all devices, the new figure of the person responsible for regulatory compliance, the Unique Device Identification system, the establishment of the European database on medical devices (Eudamed), more rigorous post-marketing surveillance and closer attention to technical characteristics.
With increasingly stringent legal requirements on the one hand and continuous development and constant technological evolution of medical devices and IVDs on the other, there is the need for documentation that not only meets legal requirements but that is also user friendly and easy to understand.
This is because medical devices and IVDs are definitely essential for doctors and pharmacologists, but also play a major role in promoting patients’ and carers’ autonomy.
With greater interaction between technology – including medical technology – and people, the translation of medical device documentation is increasingly becoming not only a legal obligation but also an ethical duty and a responsibility for those commissioning such translations and those executing them.
Given the growing use of medical devices by non-specialists, the translated information material accompanying them must be accurate, precise, clear and easily understandable.
The importance of continuing professional development
Why is continuing professional development so important for translators specialising in the field of medical devices?
Continuing professional development is essential for our profession as it allows us to understand how documentation evolves in terms of the terminology, lexicon and register of documents associated with medical devices (posters, marketing brochures, instructions for use, warranties, etc.). Keeping up to date is a must when providing a quality service. This can only be done through continuing professional development and participation in workshops, seminars and conferences.
The importance of ONLY translating what you know
In-depth knowledge of legislation, regulations and provisions, as well as manufacturer’s indications and instructions, are essential for translators as they must transfer how a device operates from one language to another clearly, correctly and intelligibly in order to reduce to a minimum any risks arising from the use of these devices.
Being informed means finding reference material, taking a close look at devices, and attending conferences and trade fairs where these devices are presented and used. This is why we attend the annual Mediterranean Health Care Forum and other trade fairs, including MedTec, where we can get to know and physically touch the devices we translate.
And, last but not least, we keep a close working relationship with our clients, ensuring a fruitful exchange of expertise and experience, and efficient problem solving.
This is why we don’t consider ourselves simply a service provider but rather a partner – someone to help you achieve your most important objectives!