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The EU-Medical Device Regulation MDR 2017/745 is applicable to all medical devices that are marketed or distributed in EU-Member States, resulting in an impact and an increase in translation needs on all medical device manufacturers, since there a total of 24 official languages. The Member State determines the languages accepted . In Croatia the Medical Devices Act was originally enacted in 2013...
[TOC] The challenge of linguistic diversity in health care We live in an increasingly globalised world. It is common to find people from different backgrounds. Many of them speak different languages. Language diversity enriches our lives, but it can also create obstacles in important sectors such as healthcare. How can we ensure that all of us, regardless of our mother tongue, receive the quality...
As part of the EU-Medical Device Regulation (MDR) implementation, all medical device manufacturers must comply with language requirements in the EU. The European Union has 24 official languages and Spanish is one of them . Spain, as one of the largest EU markets, has specific language requirements for medical devices. In this article, we will explore the language requirements for medical devices...
The EU-MDR has been active since 26 May 2021. It applies to all medical devices sold or distributed within the European Union and affects all MedTech companies. Germany has specific laws for medical device manufacturers and distributors to follow . These laws include language requirements. In Germany, the MPG (Medizinproduktgesetz) was the official regulatory law for medical devices in Germany...
Medical translation is essential to facilitate communication between healthcare workers and patients who are not fluent in English . However, it is not always possible to convey the desired message to patients or relatives, either because of a lack of resources or because a good translation is required. [TOC] 1. The challenges of medical translation Medical translations are a special challenge...
In the field of medical translation , the quality, accuracy and consistency of translations are key factors when it comes to ensuring patient safety. That is why agencies working with medical translators must adhere to strict standards to ensure quality translations. In this article we will discuss three key ISO standards for medical translation agencies : ISO 17100:2015, ISO 13485:2016 and ISO...
The EU-Medical Device Regulation (EU) 2017/745 has been in effect since 26 May 2021 , and it applies to all medical devices that are sold or distributed in all EU-Member States. This implementation has affected all medical device industries. One of the key aspects of the regulation is the language requirements that apply to medical devices. In this article, we will explore the language...
Translating is one of the most rewarding jobs, but as in any discipline, it is essential to do it as well as possible. One of the most important bases of any translation is good communication and interpretation , so that there is a good understanding between the two parties. Not all translation jobs are as complex as others, and in some sectors, changes or misunderstandings of phrases, words or...
It is likely that on more than one occasion you have had a feeling that is very difficult to describe in words. Basically they are feelings, by which human beings are characterised. Does the fact that it is difficult to express these feelings mean that they cannot be translated? We have already seen which words in the world are untranslatable. Are feelings among them? [TOC] 1. Translating...
Today we live in a modern world , where medicine is more focused on a holistic and personalised approach to patient care. The translation of medical documents is very important to help patients fully understand their health conditions and the care they receive. Among these medical documents you can find the health questionnaires dedicated to patients . Health professionals should create a patient...









