MEDIcept Insights
EU AI ACT and Its Impact on the Medical Device Industry
The provisional agreement on the Artificial Intelligence Act proposed by the European Parliament introduces a unified regulatory framework for AI across the EU, with significant implications for the medical device industry. This paper aims to discuss the potential...
NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”
The use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and studies for FDA regulated medical products is essential for all medical product manufacturers. ...
European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption
The European Commission is considering extending the transition period for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) due to concerns that manufacturers might not have sufficient time to comply. The IVDR came into force in May 2022, and...
FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov
The prompt and precise registration, as well as the timely dissemination of comprehensive summary results information for relevant clinical trials on ClinicalTrials.gov, play a pivotal role in providing current research insights to various stakeholders within the...
MHRA Releases Roadmap of Future UK Medical Device Regulation
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has revealed a roadmap for medical device regulation, aiming to prioritize patient safety and establish a new framework by 2025. As released on January 9th, 2024, the agency plans to implement priority...
Understanding Digital Health Technologies (DHTs) in Clinical Trials
Digital health technologies (DHTs) are becoming more prevalent in clinical investigations and having the correct knowledge on how to utilize these technologies is essential if you choose to implement them. On December 21, 2023, FDA released the final guidance...