Directive 90/385/EEC → MDR: AIMDD Repeal, Article 120 & Manufacturer Actions | Dr. Ashish Jha

About Video:
This video explains how Directive 90/385/EEC (the Active Implantable Medical Devices Directive, AIMDD) was replaced by Regulation (EU) 2017/745 (MDR), what that repeal means in practice for active implantable devices, and the concrete steps manufacturers must take to remain compliant. We cover the legal repeal and transitional timeline, Article 120 legacy device rules, where AIMDD obligations continue to apply temporarily, and the practical manufacturer checklist (gap analysis, updated clinical evidence, Notified Body engagement, UDI/EUDAMED, PMS/PMCF and vigilance)


Welcome:
Welcome to a knowledge-driven platform dedicated to the latest advancements in Medical Device Regulation, Pharmaceutical Research, Biotechnology, and Nanotechnology in Medicine. This channel explores how science and innovation—ranging from Biomedical Engineering and Analytical Instruments to Curcumin Nanoparticles and Nanomaterials in Drug Delivery—are shaping the future of healthcare. We also highlight important topics in Cancer Research, Immunology, and Photothermal Therapy, with a special focus on Health Technology, Medical Innovation, and Regulatory Affairs. Featuring insights inspired by institutions like IIT Bombay and thought leaders such as Dr. Ashish Jha, our mission is to promote education, innovation, and global health awareness. Whether you're a student, professional, or enthusiast in STEM, Biomedical Devices, or Public Health, this channel offers valuable content that supports ethical science, responsible innovation, and informed healthcare decisions.

About Dr. Ashish Jha:
Dr. Ashish Jha is a Ph.D. graduate in Nano & Bio Technology from IIT-Bombay, specializing in nano formulation development, in-vitro & in-vivo characterization, and cancer therapy. His research focuses on developing plasmonic nanoparticles for photothermal therapy in breast cancer. He aims to apply his academic and industrial expertise to solve critical challenges in the field of nanotechnology and biotechnology.

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