EU Medical Device Directive to MDR Transition | Clinical Research & Regulatory Training скачать в хорошем качестве

EU Medical Device Directive to MDR Transition | Clinical Research & Regulatory Training

EU Medical Device Directive to MDR Transition | Clinical Research & Regulatory Training This clinical research certification lesson provides foundational knowledge on the transition from the EU Medical Device Directive (MDD) to the Medical Device Regulation (MDR). As part of structured clinical research training, it explains why the regulatory shift occurred and how MDR requirements directly affect clinical trials, device development, and regulatory compliance across the EU. Learners examine key differences between MDD and MDR, including strengthened clinical evidence requirements, post-market surveillance obligations, risk classification changes, and expanded responsibilities for sponsors and manufacturers. The lesson connects these changes to real world clinical trial responsibilities such as protocol design, clinical evaluation reports, safety reporting, regulatory documentation, and inspection readiness. This topic is especially relevant for regulatory affairs and pharmacovigilance professionals, clinical research associates, project managers, and investigators involved in medical device studies or combination products. Understanding the MDD to MDR transition is critical for maintaining compliance, ensuring data integrity, and supporting successful regulatory submissions within evolving European regulatory frameworks. This lesson is part of the Advanced Pharmacovigilance & Regulatory Affairs Certification (APVASC) within the CCRPS clinical research certification ecosystem. The program supports professionals seeking globally recognized clinical research training aligned with regulatory expectations for medical devices, clinical trials oversight, and lifecycle compliance. CCRPS delivers globally recognized, triple accredited clinical research training aligned with CPD, ACCRE, CE, NHA, and TransCelerate standards. Our programs are designed to mirror real world clinical trial execution across sites, sponsors, CROs, and regulatory environments. Learn more: https://ccrps.org Explore programs: https://app.ccrps.org Call advising: +1 801 515 4867 Educational Disclaimer: ------------------------------------- The content provided on this channel is intended for educational and informational purposes only. CCRPS does not provide medical advice, clinical treatment recommendations, legal guidance, or professional services through this content. All information shared is based on general principles of clinical research, regulatory standards, and industry practices and should not be considered a substitute for professional judgment, institutional policies, or regulatory requirements. Viewers are encouraged to consult qualified professionals, official guidelines, and regulatory authorities before applying any information in clinical, research, or professional settings. CCRPS assumes no responsibility for actions taken based on the content presented in these videos.