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)
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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About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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