Ensuring quality medical translations according to the new MDR and IVDR regulations

What does medical translation involve?

Medical translation has always required, but today more than ever, precision and up-to-date technical knowledge, as well as high levels of quality control and understanding of the legal and regulatory context.

With the advance of health and innovation, medicine is taking on a global format that breaks down borders and shares a common market with thousands of languages in the world and 24 official languages in the European Union (EU) alone.

Challenges and difficulties in medical translation

Language plays a key role in the EU compliance of medical device manufacturers and other healthcare-related parties. Aspects such as labeling and other content that require translation must meet a very high level of accuracy and specificity in order to ensure safety of patients. 

That's why medical device companies need a trusted partner who they can count on when it comes to getting qualified translations that meet the relevant requirements. This is necessary for the correct allocation of translation resources, as the lack of it could trigger the loss of EU certification.

What are MDR and IVDR and why should they be considered in medical translations?

The new EU medical device regulations, effective from May 2021, involve a change in legislation in the industry related to classification, monitoring and new requirements for medical devices and instruments. The aim of these regulations is to enhance the traceability and safety of such devices.

MDR: Medical Device Regulation

The European Union medical device regulation 2017/745, also known as the EU MDR, is a new clause that applies to any medical device manufactured or supplied in the EU.

In order to be marketable, the MDR requires a clinical evaluation report in order to be able to identify the devices correctly and to be able to standardize the data and the technological advances in such devices. Once marketed, they must undergo continuous clinical monitoring.

IVDR: In Vitro Diagnostic Medical Devices Regulation

The European Union In Vitro Diagnostic Medical Devices Regulation 2017/746, also known as the EU IVDR, is specifically applicable to this type of devices dedicated to diagnosing medical problems.

To be commercially viable, the IVDR requires a much more thorough performance evaluation than the previous IVDD (In Vitro Diagnostic Medical Devices Directive). As a result, more and more companies are required to register with a notified body and require continuous monitoring to ensure that their certification and technical documentation complies with all new requirements.

Why have language and translation become even more important with the MDR and IVDR regulations?

The implications of language and medical translations play a vital role in being able to fulfill the promise of transparency and robustness supported by the new regulations. Instructions for use, for example, are part of the technical file of the device and must be sent together with the labeling to the notified bodies for thorough review.

In addition to the labeling and instructions for use, translations are required in numerous situations, including liaising with authorized bodies, translating the EU Declaration of Conformity, and dealing with many other documents that have to be translated efficiently and reliably.

4 factor to consider when applying the MDR and IVDR to medical translation projects

European manufacturers must be prepared to translate all types of documentation into any of the 24 official EU languages. Only a quality translation will ensure the safety and proper use of medical devices in accordance with the law and, to achieve this, the following factors must be taken into account.

1. Scalable translation resources

Regardless of whether the device is intended for professional or non-professional use, it is important to have a scalable and reliable translation resource that can cope with the scope and scale of the increasing translation demands imposed by the EU. 

The wide range of content types and variety of official languages can be a barrier to entering new markets with different language requirements. That's why it's important to invest in a flexible model to meet the deadlines for CE marking certifications (in the case of Europe).

2. Considering context and terminology 

It's not just about words. In medical translation and interpreting, the context, terminology, abbreviations, symbols and icons may also be affected.

In order to provide these specialized translation services, deep technical knowledge, both clinical and country-specific, is required. The expertise to create user-focused content must have the appropriate level of literacy and expression in the language of the member state.

3. Taking into account the usability of the devices

The new EU regulations underline the importance of the clarity of the language used, especially in the content created for the intended user. This approach must differentiate between a more technical approach for professionals (B2B) and an easily understandable approach for the end user (B2C).

In addition, consideration should also be given to the translation or adaptation of diagrams or text on supplementary drawings.

4. The importance of human knowledge

In texts as specialized as medical translations, the brand names used for marketing, hospital structures, titles of different providers, and types of authorized procedures can be as different as the guidelines and regulatory bodies. 

For this reason, the texts are translated and revised by native professionals with experience in the medical field in order to ensure absolute accuracy in the translations and information provided.

Pangeanic as your partner in medical translation services

A successful medical translation service is aligned with the new compliance requirements and includes a content review and translation process that provides clarity and accuracy in all languages from the outset, resonating with the target audience.

At Pangeanic we provide highly technical and advanced machine and human translation services. Our expert linguists have a strong track record in translating medical device and healthcare-related documentation. Contact us so that we can offer you a tailor-made medical translation plan!