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Medtech Europe Survey – IVD manufacturer,
in Uncategorized
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CEN and CENELEC announced their new website,
in Uncategorized
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New standard: EN ISO 20417:2021 Information to be supplied by the manufacturer,
in Uncategorized
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MDCG 2021-23 Guidance on certification activities – MDR-IVDR,
in Uncategorized
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MDCG 2021-22 Clarification on first certification – IVDR,
in Uncategorized
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MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices,
in Uncategorized
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MDCG 2021-20 CIV-ID for MDR Clinical Investigations,
in Uncategorized
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MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system,
in Uncategorized
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New forms for Notified Bodies in the scope of the MDR and the IVDR,
in Uncategorized
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MDCG 2021-11 Guidance on Implant Card – Device types,
in Uncategorized
