16 March 2021

Medical devices: what are they and where does translation come in?

Categoria: Translation

They’ve become a more integral part of our lives than ever before. We wear them every day, they’re spoken about on television all the time and we see them being used by the people around us constantly.

What are we referring to? Medicaldevices, of course!

Surgical masks, serological tests, gloves and testing kits are just some of the medical devices used in the healthcare industry every single day.

But what really are they? A definition can be found in Italian Legislative Decree No.46 of 24 February 1997, which was passed to implemented European Directive 93742/EEC.

According to the decree, a medical device is:

  • any instrument
  • apparatus
  • appliance
  • substance
  • or other product


used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:


  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process;
  • control of conception


and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”


The delicate, complex nature of these devices is immediately clear from this definition. It should come as no surprise, then, that in order to obtain the CE mark (a four-digit symbol located on the back of the device that certifies its suitability for sale), a device needs to undergo a series of clinicaltrials to ensure that it has the required attributes for use. And guess what? Translating the medical/scientific documentation that accompanies these devices is every bit as complicated as you might expect.


Translation for medical devices: the requirements


There are two main categories of medical device users: industryprofessionals and patients.

In both cases, it’s vital that the documentation accompanying these devices be easy to understand.

Translation accuracy of this kind of documentation is of vitalimportance, because inaccurate translations could lead to improper use of the device, something that risks compromising patient safety.

To avoid complications, the European Directive we mentioned above set out a specific process for multilingual documentation in this field. However, the attributes a translation requires to be considered “accurate” and compliant with the directive are still rather vague. One thing’s for sure, though: using a non-professional translator to translate documents full of specific technical and scientific documentation is the wrong way to go.

Professionalism and rigor are fundamental requirements for medical/scientific translation.

Translating a document containing information on medical devices requires:


  • An extensive understanding of both the source and target language for the document;
  • A specialization in the medical and technical/scientific sectors;
  • Ongoing professional development and broadknowledge of the current status of the industry.


In addition to these three core requirements, it’s also vital that translators be familiar with the latest technology used in the language industry. By harnessing the power of these cutting-edge tools, they are able to boost the quality of their translations.

Last but not least, it’s important that a translation project in this sector include multiple proofreading, review and quality control steps to ensure that the translation fully reflects the content of the original text.


At Way2Global, we’re experts in fulfilling all these requirements. We have a team of native-speaker translators with specialist skills and multiple years of experience in the medical and scientific sector. Our translators are committed to professional development and keep their fingers on the pulse of all the latest developments – and they use the most sophisticated technology to guarantee translation quality.

Our projectmanagers coordinate and oversee every project to ensure that we deliver on time, while also guaranteeing the accuracy of official terminology and making sure that the translation faithfully reflects the original. And our workflow also includes several checks and balances, all designed to guarantee impeccable results.

We draw on all our professionalism and meet the highest possible standards medical industry translations. Quite simply, we know that good translation is essential to ensuring that medical devices be used correctly, with significant implications for patient health and personal wellbeing.


Need a translation for the medical sector? Contact us!