Tag: free

The Medical Device Regulation (MDR) is a piece of European Union legislation that regulates the marketing and use of medical devices in the EU market. The regulation was published in 2017 and will come into force in 2021. The MDR is the most comprehensive and demanding regulation of medical devices in the history of the EU.

The aim of the MDR is to ensure a high level of safety of medical devices for patients. The regulation introduces many new requirements that medical device manufacturers must comply with. One of the most important requirements of the MDR is the use of compliant terminology.

MDR terminology is the terms and their definitions that are listed in this regulation. This terminology is critical because it helps ensure compliance with the MDR by all participants in the medical device market.

Benefits of using the MDR Terminology Glossary

Available in 24 languages (Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish), the MDR Terminology Glossary is an indispensable tool for both medical device manufacturers and translation agencies. In a regulatory world where accurate understanding and use of terminology is critical, such a glossary can save valuable time and effort. It allows translators to be confident that their translations are compliant with the MDR.

Failure to use MDR-compliant terminology can have many negative consequences, including

1. The medical device may not be approved for the EU market.
2. The medical device may not comply with MDR requirements.
3. The patient may be exposed to risks associated with the medical device.
4. The medical device manufacturer may be fined or otherwise sanctioned.

To avoid these consequences, medical device manufacturers must use MDR-compliant terminology.

MDR Glossary

The creation of our MDR Glossary was a meticulous and careful process. The terms and definitions included are taken directly from the MDR, so the process of selecting and translating them was overseen by medical device experts and professional translators specializing in the field from the creation of the MDR itself. This makes the glossary a solid and reliable resource for manufacturers and translators.

To further enhance the usefulness of our glossary, translation agency translax makes it available in several popular formats. For those who appreciate simplicity and versatility, the glossary is available in XLSX format (with term definitions in note form), which is compatible with most spreadsheet programs such as Microsoft Excel. This allows you to easily search, sort and filter terms according to your needs.

FREE DOWNLOAD: XSLX

For translators using tools such as Trados Studio and Multiterm, translax has prepared a glossary (the terms themselves) in XML and SDLTB formats. These formats make it easy to use in CAT tools, thus enabling efficient use of the glossary when translating medical device documentation.

DOWNLOAD FREE: XML and SDLTB

Benefits of using a medical translation agency

A medical translation agency is the best choice for professional translation of medical device documentation. Translax ensures that translations are accurate and compliant with MDR requirements.

The MDR is the most comprehensive and demanding medical device regulation in the history of the EU. Medical device manufacturers must use MDR-compliant terminology to avoid the negative consequences of non-compliance.

If you need assistance translating medical device documentation, please contact us: