• ANVISA New Medical Device Regulation RDC 751/2022

    27 June 2023 EU MDR
    On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the ...
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    UK MHRA Extending Acceptance of CE Devices

    23 June 2023 EU MDR
    The Medicines & Healthcare products Regulatory Agency (MHRA), which oversees medical devices in the ...
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    New EU MDR/IVDR Authorized Representative guidance summary

    9 November 2022 EU MDR
    For manufacturers who are not established in the European Union, the authorized representative ...
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    2021 Warning Letters list from FDA for Med Devices

    25 February 2022 EU MDR
    S.No Date Warning Description Manufacturer Product(s) Summary 1. 25-Jan-2021 CDRH ...
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    ISO 15223 Labeling New Version Changes

    10 February 2022 EU MDR
    ISO 15223-1 Gap Analysis EN ISO 15223-1:2016 EN ISO 15223-1:2021 ...
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    Harmonised Standards for Medical Devices in Support of Regulation (EU) 2017/745

    8 February 2022 EU MDR
    The European Commission officially recognized nine harmonised standards for medical devices in ...
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