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Attention medical device manufacturers! The Medical Devices Regulatory — support unit (MDRu) informs you about the publication of the new Regulation (EU) 2024/1860, which brings important changes to the sector.
Main changes:
– Gradual implementation of EUDAMED: The EUDAMED platform will be implemented gradually, with specific deadlines for different types of devices.
– Obligation to inform in the event of interruption or discontinuation of supply: Manufacturers are now obliged to inform the competent authorities and distributors in the event of interruption or discontinuation of supply of their products.
– Transitional provisions for certain in vitro diagnostic medical devices: Class A and B in vitro diagnostic devices will have different deadlines to comply with the new rules.
MDRu can help you understand and adapt to the new requirements of Regulation (EU) 2024/1860.
Contact us today to find out more about how we can help you ensure the compliance of your medical device: https://lnkd.in/dreiWTp7