24/10/2023

Medical technology is an elementary component of the German healthcare system and the German economy. The industry is subject to stringent requirements and regulations that affect production and application as well as technical documentation and its translation. Reason enough for us to take a closer look.

Medical technology, also known as health technology, is the application of engineering principles and rules in the field of medicine and health sciences. It serves the development and manufacture of products, devices and procedures for the prevention, diagnosis and treatment of disease. All of the industry’s solutions and products aim to improve quality of life and increase the productivity of hospitals and medical practices.

Given this position, medical technology is a dynamic sector that brings an above-average number of new products to the market. Over 50% of turnover is generated by the sale of products that have been on the market for less than three years.

Medical technology is particularly well-established in Germany (only available in German), where over 25% of European medical technology manufacturers are located. If you take a closer look, medical technology is of great importance in Baden-Württemberg (only available in German). With 25% of national sales, our home state is a leader in medical technology in Germany. It is where you will find more than 850 companies cooperating with 44 research institutes and universities as well as five university hospitals.

Since the Medical Devices Regulation EU 2017/745 (MDR) came into force [] in 2021, particular attention has been focused on the industry.
The MDR serves to increase patient safety with respect to medical technology products. It comprises numerous regulations and specifications for medical and medical technology product information and its translation.

In addition to very stringent requirements for quality and risk management and numerous details regarding clinical evaluations, the regulation focuses on technical documentation. Its specifications include, for example, continuously updating to the latest version and the associated translation of amended parts of a text.

The requirements for the language of documents impact directly on translation and the translation process, which we explain in more detail below.

Firstly, it should be emphasised that certain translations, such as instructions for use, are considered part of the technical documentation and must therefore be written prior to the conformity assessment procedure and CE certification. It is therefore important for manufacturers and providers to bear in mind that translations must be scheduled early on in the process.

It is equally important that all information relating to the product must be available in every official language of the country in which the product is sold and used. In accordance with EU Official Journal L 117 , all information must be provided in a form which is “easily legible and clearly comprehensible to the intended user or patient”. At the request of the competent authorities, companies must also be able to provide all evidence of conformity, clinical trials, evaluations and more in the relevant official language.

It should also be noted that product names, for example, must also be translated if they provide information about product usage. Every medical technology product must be available with all information in the appropriate national language in order to clearly identify the product and its function.

The language accepted for the technical documentation is determined by the individual countries themselves. While most countries only allow their own official language, the Netherlands, Cyprus, Finland and Iceland also accept documents intended solely for professional use in English.

The situation is different in multilingual countries such as Switzerland, which require translations in all official languages. Iceland, which has already been mentioned, differentiates even more specifically because documents of relevance to patients must be in Icelandic.

Depending on the form of distribution and the number of countries in which medical products are sold, translations can be required in up to 24 languages in the EU alone.

The stringent technical standards and regulatory requirements result in a compelling need for content and translations that are precise, contain the correct terminology and are comprehensible for all target groups. In few areas is the need for translation-oriented writing more evident than in medicine and medical technology.

Especially in this sensitive area, texts to be translated should be written with clear, consistent and precise wording and correct information. To avoid misunderstandings, authors must avoid ambiguities and unclear references as well as country- and culture-specific elements, examples or references.
It’s important and helpful to define in advance clear and consistent terminology including unambiguous terms and to use glossaries. Correct formatting is also essential if using translation technology in the form of CAT tools or translation memory systems, as is commonplace and necessary in the modern translation process.

To fulfil all these criteria, it’s essential for manufacturers and providers of medical technology solutions to partner with a qualified and certified language service provider to deal with all the necessary details.

Thanks to our ISO 17100 certification (“Requirements for translation services”) and our expertise through our collaboration on DIN 8579, our network of highly trained native-speaker specialist translators and our technically advanced services, e.g. in terminology management, we are one such partner. We guarantee consistent, high-quality translations that meet the quality requirements of the medical technology industry at all times and in every language.

Do you need professional, secure and high-quality translations in medical or medical-technical communication? Contact us. Our experts in medical translation will be happy to advise you on the options available to you.