What is MDR? Key Translation Points Medical Device Manufacturers Should Know

1. What is MDR? Basic Overview of the European Medical Device Regulation

1-1. What is MDR (European Medical Device Regulation)?

MDR (Medical Device Regulation) is an abbreviation for Medical Device Regulation and is a regulation that must be complied with when selling medical devices in the EU. It applies to medical devices and their accessories. It came into effect in 2017 with the aim of ensuring safety and performance, and has been fully applied since May 2020. It replaces the previous MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive), featuring stricter standards.

1-2. Requirements for Medical Devices under MDR

MDR sets forth the following requirements.

・Basic Requirements: Medical devices must be safe and effective for their intended purposes. This includes detailed standards regarding the design, manufacture, and performance of the devices.
・Classification: Medical devices are classified into Classes I to III based on risk, with stricter regulations applied to higher classes.
・Clinical Evaluation: It is necessary to demonstrate the safety and performance of medical devices based on clinical trials and existing data.
・Post-Market Surveillance: Continuous monitoring of safety and performance after the device is placed on the market is required, with corrective actions taken as needed.
・Technical Documentation: Manufacturers must create and maintain detailed technical documentation regarding design, manufacture, and performance. This documentation must include information on product safety and clinical performance and be provided in a language understandable to users.
・Obligations of Economic Operators: Manufacturers, importers, distributors, and other economic operators must fulfill their respective responsibilities and obligations.

In addition, conformity assessment procedures are established according to the class and risk of the medical device, and to sell in the EU, it is necessary to pass this assessment and prove that the MDR requirements are met.

2. The Importance of Translation in MDR

2-1. Potential for Market Expansion through Multilingual Support

Japan's medical device market continues to grow due to an aging population and advances in medical technology. As the domestic market matures, overseas expansion is accelerating, and digital healthcare utilizing AI and IoT is also contributing to market growth.

In this context, multilingual translation is an indispensable factor for market expansion. By approaching customers who speak different languages, product recognition and reliability improve, leading to increased sales. Communication in the local language is also effective in strengthening brand power.

Furthermore, MDR mandates that technical documents, user manuals, labels, and the like be translated into the official languages of EU member states, making translation compliance legally essential.

Reference: Medical Device Market and Medical Device Translation – Focusing on Comparison with Pharmaceuticals

2-2. What Constitutes Accurate Translation Required for MDR Compliance

Technical documents related to medical devices contain specialized and detailed content, so accurate translation is required. Any mistranslation may affect the conformity assessment under the MDR and could hinder the product's market launch.
Therefore, to ensure translation quality, it is essential to utilize translators with specialized knowledge and quality management tools. Many companies collaborate with professional translation vendors to enhance the accuracy and reliability of translations.

3. Human Science's Translation Solutions Supporting MDR Compliance

At Human Science, we provide multifaceted support for the translation requirements necessary for MDR compliance.

3-1. Translation Support by On-site Coordinators

We introduce a case where translation coordinators and layout checkers for 25 languages are stationed at the client's site to manage project progress. Among destination management in 25 languages, translation in 25 languages, translation checking, DTP, and layout checking, the on-site members handle coordination tasks and layout checks. Even when multiple product development lines run concurrently, by utilizing Human Science as a back office, we provide sufficient capacity. We also meet strict security requirements and support remote work arrangements.

3-2. Achieving High-Quality Translation through Collaboration with Medical Teams

In medical device translation, highly specialized content and the latest medical knowledge are required, making collaboration with the medical team indispensable. Our company has a dedicated medical translation group, and medical specialist translators participate in the translation process to thoroughly check terminology consistency and content accuracy. This ensures high-quality translations that meet MDR requirements while also securing practicality and safety in the field.

We have a wide range of translation experience not only with medical device user manuals but also with clinical trial-related documents such as protocols, IBs, and CTDs.

>Medical Device Translation Services

3-3. What Are Human Science’s Translation Solutions?

Our human science translation services handle not only large volumes of translation but also cost reduction through the use of machine translation, as well as translations that reflect local laws and standards.
If you have concerns about quality, deadlines, or costs, please feel free to contact us first.

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