European Commission’s Guidance for Joint Clinical Assessments
In an effort to streamline and enhance the evaluation of health technologies across Europe, the European Commission has released a comprehensive guide focused on the validity of studies for joint clinical assessments (JCAs). This initiative, rolled out under the EU Health Technology Assessment Regulation (HTAR), represents a significant step toward harmonizing the assessment of new […]
The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
As artificial intelligence (AI) and machine learning (ML) technologies rapidly evolve, their integration into medical devices is transforming healthcare. From diagnostic tools to treatment algorithms, AI/ML-enabled devices offer significant benefits but also pose unique regulatory challenges. Technology in medical device applications is shifting and digital health is becoming more a part of every-day healthcare, through […]
EMA Launches a Pilot Program on Orphan Medical Devices
In a significant move to address a critical gap in the healthcare industry, a new pilot program has been launched to support orphan medical devices. On August 2, 2024, the European Medicines Agency (EMA) announced that its effort, as mandated under Regulation (EU) 2022/123 (Regulation – 2022/123 – EN – EUR-Lex (europa.eu)), aims to provide […]
MDCG Revises Guidance on Classification for In Vitro Diagnostics
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that […]
The EU AI ACT: Implications for the Medical Device Industry
The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]
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 […]
