Cutting Edge Regulatory Updates

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  • February 28, 2023

    Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]

  • EU IVDR Regulation

    February 22, 2023

    IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The PIP breast implant scandal brought to light weaknesses in the overall regulatory [...]

  • EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions

    February 21, 2023

    The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in vitro diagnostic regulation. While the medical device regulation did not [...]

  • Literature Review

    February 18, 2023

    Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation [...]

  • CER Writer

    February 17, 2023

    Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to [...]

  • Software as a Medical Device

    January 24, 2023

    The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]

  • Vigilance Reporting Under the MDR

    January 17, 2023

    Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations. [...]

  • UK MDR

    January 10, 2023

    UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there [...]

  • Regulatory Updates

    January 3, 2023

    2022 was quite the year. While the pandemic slowly fizzled, medical device companies and medical writers enjoyed new guidelines and regulations, first-row seats to the biggest recall in FDA history, and a bunch of odd [...]

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