Navigating the EU Clinical Trials Regulation (CTR)

The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation of clinical research within the EU. Enacted to streamline and harmonize the conduct of clinical trials across member states, the CTR aims to enhance patient safety, promote transparency, and facilitate the timely initiation and completion of clinical research. As the […]

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 […]