Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers
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Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers
Regulatory Affairs EU MDR EU IVDR
Tuesday, 23 January 2024
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.
On January 17th, 2024, the European Commission EU Health and Food Safety (DG Sante) has published an overview of the language requirements for manufacturers of medical devices. The Commission and Member States have created specific tables for MDR and IVDR.
IVDR – National language requirements for manufacturers (January 2024)
MDR – National language requirements for manufacturers (January 2024)
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.
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