This module provides a comprehensive introduction to the global and regional regulatory frameworks governing the medical device industry, including key authorities, device classifications, and post-market requirements. Students will explore core regulatory principles such as risk management, quality systems, human factors, and ethical considerations throughout the design and approval processes. Emphasis is placed on effective communication of regulatory and ethical issues to both technical and non-technical audiences, with additional focus on environmental impacts and sustainability regulations affecting medical device development.
Introduction to the Medical Device Regulation: What is a medical device? What are regulations and why are they necessary? Ethics/Bioethics how do they inform design?
Major Regulatory Jurisdictions: Global Regulatory Context: Regulatory Stakeholders: WHO, European, US, International Medical Device Regulatory Forum, Global medical Devices Nomenclature system, Unique Device Identification. European Regulatory Environment: European Medical Device Regulation MDR 2017/745, in-vitro diagnostic Regulation IVDR 2017/746. US regulatory Environment: FDA, Center for Devices and Radiological Health (CDRH), CFR Title 21-800.National Regulation: Medical Devices Industry in Ireland. Healthcare Products Regulatory Agency (HPRA/IMO).
Management of Risk: Why are we concerned about risk? How can we measure and mitigate against risk? How can we implement regulations depending on the risk to the patient? Design Control Process Overview & Device verification. Medical Device Classification, Risk Management, Quality Management. Medical Device Recalls, Management of recalls, Key recall incidents. Human Factor Engineering.
Emerging Regulations: Environmental regulations, impact of standards and codes from other regulatory areas can impact upon the regulatory process.
Medical Device case studies: Functionality, user, patient, classification, risk, design features, bench testing (design verification), design validation (clinical trial etc), post market issues, etc.
Guest lectures: Invited speakers from a notified body or competent authority or a device manufacturer.
