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Medical Devices – Latest News
MDCG guidance alert: New MDCG 2024-16 guidance on how to deal with interruption or discontinuation
New MDCG guidance provides an information form for MD and IVD manufacturers to...
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MDCG 2022-5 Rev.1: Updated guidance on borderline products
Revised MDCG 2022-5 Rev.1 aims to improve classification of borderline products with new...
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MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
MDCG 2024-13: EtO is subject to the MDR/IVDR, although EtO as a substance...
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TEAM NB press release on transition to the implementation of Class D IVDs oversight by EU reference laboratories
Class D in vitro diagnostic medical devices must be tested by an EU...
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MDCG 2021-25 Rev. 1: MDCG publishes revised guidance on the application of MDR requirements to legacy devices
MDCG revises its guidance on the application of MDR requirements to legacy devices
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