The EU IVDR Impact on Clinical Trials

The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]

EU Commission proposes another extension for IVDR transition

On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period.  Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time […]

MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS

The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]

MANAGING CHANGES AND MAINTAINING COMPLIANCE

Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]