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Notice to manufacturers to ensure timely compliance with MDR requirements,
in Uncategorized
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Regulation (EU) 2023/2197 on assignment of UDIs for contact lenses published,
in Uncategorized
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MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations,
in Uncategorized
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European Commission published Q&A on MDR Annex XVI,
in Uncategorized
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IMDRF: Personalized Medical Devices – Regulatory Pathways,
in Uncategorized
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TEAM-NB: Tripartite agreement between manufacturer, outgoing MDD-NB and incoming MDR-NB,
in Uncategorized
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Newly released flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period,
in Uncategorized
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MHRA published infographic on timelines for placing CE marked IVDs and medical devices on the Great Britain market,
in Uncategorized
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Notified Body confirmation letters in the framework of Regulation (EU) 2023/607 and (EU) 2024/1860,
in Uncategorized
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Q&A published on MDR extension (Regulation (EU)2023/607),
in Uncategorized
