---
title: "Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers"
description: "EU Commission publishes language requirement tables for MDR and IVDR to help medical device manufacturers meet language compliance across EU Member States."
url: https://qbdgroup.com/zh-cn/regulatory-updates/comprehensive-overview-of-language-requirements-under-ivdr-mdr-for-medical-device-manufacturers
type: "Regulatory update"
language: zh-cn
published: 2024-01-23
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers\", https://qbdgroup.com/zh-cn/regulatory-updates/comprehensive-overview-of-language-requirements-under-ivdr-mdr-for-medical-device-manufacturers"
---
# Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers
> EU Commission publishes language requirement tables for MDR and IVDR to help medical device manufacturers meet language compliance across EU Member States.

Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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##### EU Commission published MDR and IVDR language requirement tables for medical device manufacturers, aiding compliance with linguistic regulations across Member States.

[IVDR – National language requirements for manufacturers (January 2024)](https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf)

[MDR – National language requirements for manufacturers (January 2024)](https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The tables provide an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers.

[![Regulatory Affairs](https://no-cache.hubspot.com/cta/default/7030766/interactive-182180411307.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLLgz%2FXFCVvRp%2FQqpuz89rr80ERliFrVnUo2l442ho8jHfY1noOlmervnaJW4r7i8N2L8njgii2ryQ5VGCLKIQwbjtXiIbi1WsCD9M8zfPcNCn%2BCRD4Ol0kdiw%2B4tsrdI8e8NA%2Bh7A3iSt3CRdrT8X%2BY8E9y5hlAkW0UpRizvLKHK6aXyyo3tumUG8ci5ZuS5wSqTVYPYQQM&webInteractiveContentId=182180411307&portalId=7030766)
## with ease.
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Source: https://qbdgroup.com/zh-cn/regulatory-updates/comprehensive-overview-of-language-requirements-under-ivdr-mdr-for-medical-device-manufacturers — © QbD Group. Quote freely with attribution and a link back.