Medical devices, MDR, and translation: what you need to know

medical devices mdr translation

Medical devices, MDR, and translation: what you need to know

Medical devices are essential to hospitals, clinics, and surgeries and require the utmost care in production, marketing, and export stages. In the latter context, correct translation is absolutely crucial. In today’s article, we will explore the link between medical devices, MDR, and translation.

To protect the public health of European citizens, the Medical Device Regulation (MDR) came into force in the European Union on 26 May 2021. It replaced the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

The MDR regulation includes several rules to ensure medical devices marketed in the European Union are safe and effective. It also aims to strengthen product transparency and traceability. Ensuring patients and healthcare professionals have access to clear and accurate information on the performance, use, and safety of medical devices.

The MDR is applicable to a wide range of medical devices. Including diagnostic products, surgical instruments, prostheses, monitoring equipment, life-support devices, and many others.

In this context, of course, translation also plays a key role. MDR standards set specific requirements for exporting products to other EU countries. Today we want to take a closer look at this specific aspect. In the following paragraphs, we will analyze in detail the combination of medical devices, MDR, and translation.

Medical device translations are only part of the medical translations we have been dealing with for almost ten years now. If you would like to know more about how we work in this specific translation field, you can download our free case study.


The rules of the MDR regulation

Before delving into the relationship between medical devices, MDR, and translation, let us look in detail at the rules established by the European MDR regulation.

  • Classification of devices: first, the MDR states that medical devices should be classified according to their level of risk (class I, IIa, IIb, III). Their classification will then determine different applicable evaluation and authorization procedures.
  • medical devices mdr translation rulesAuthorization: medical device manufacturers will have to obtain authorization before they can market their products in the European Union. This will require an assessment by a notified body that verifies the medical device’s compliance with MDR requirements. Among other things, the technical documentation, the design, and manufacture of the device and, of course, the device itself in a clinical context will have to be analyzed.
  • Labelling: devices will have to be accompanied by a label indicating the information required for safe and effective use of the product.
  • Post-market surveillance: manufacturers will also be required to conduct post-market surveillance of their devices and to inform the relevant EU authorities in case of adverse events, device defects, or other issues.


Medical devices, MDR, and Translation: everything you need to know

In addition to the rules we have outlined in the previous paragraph, the MDR also lays down specific requirements regarding the documentation of medical devices. All material must be available in all official languages of the EU countries where the product will be marketed.

Consequently, the correlation between medical devices, MDR, and translation seems clear. Effectively translating the necessary documentation will be crucial for exporting one’s products in compliance with the MDR regulation.

Of course, when we talk about documentation, we are referring not only to instructions for use but also to product labeling and safety warnings. As well as performance information and product handling notices.

Correct translation will, therefore, be crucial, as it will allow safety and product performance information to be effectively communicated to a global audience. It should also be noted that failure to understand the information (as a result of partial or incorrect translation) could cause serious damage to patients’ health, leading to essential consequences for device manufacturers as well.


The Peculiarities of Medical Translation Under the MDR

Among the aspects that must be paid attention to when trying to reconcile medical devices, MDR, and translation, we cannot fail to mention:

  • Importance of technical terminology: medical and technical terminology may prove to be very complex and specific. It will, therefore, be essential to rely on expert translators who are familiar with the terms related to the use of the medical device in question.
  • Reference regulations: medical device documentation will naturally have to comply with the regulations and laws of the destination country. Therefore, translators should have a thorough knowledge of the regulations and laws of both countries involved.medical devices mdr translation terminology
  • MDRcompliance: all documentation must comply with the European Medical Device Regulation, which requires a high level of accuracy and completeness in documentation. Medical translators should, therefore, be well aware of the MDR requirements, ensuring maximum compliance. As mentioned above, poorly translated documentation may omit important information such as instructions for use, warnings, contraindications, and side effects of the device in question.
  • Cultural adaptation: medical device documentation will, of course, also need to be adapted to the cultures of the countries in which the product will be sold while at the same time not leaving out fundamental and essential information.
  • Review and quality control: the translated text will then have to be reviewed and checked to ensure that the translation is correct and complies with regulations, thus protecting manufacturers and patients from risks and dangers.


Creative Words is an ISO-certified translation agency that has been working with companies in the industrial sector in all parts of the world for years. If you need to translate important documents for your business, contact us obligation-free: we will evaluate your situation and needs together with you and propose a solution in line with your needs, expectations and budget.


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