The module aims to provide the student with a broad understanding of the various regulatory requirements required for bringing a medical device to market. It will provide an overview of the medical device industry both globally and nationally, covering the European medical device directives and US codes of federal regulation, the national regulatory groups, and notified bodies, and the ethical codes associated with each region.
Introduction to the national Medical Device industry
Review of the Medical Devices Industry in Ireland and worldwide. Current areas of operation, opportunities for growth and development and the future direction of the industry.Healthcare Products Regulatory Agency (HPRA/IMO).
Global Regulatory Context
Regulatory Stakeholders: WHO, European, US, Asian , Global Harmonisation Task Force(GHTF), International Medical Device Regulatory Forum (IMDRF), Global medical Devices Nomenclature system, Unique Device Identification (UDI).
Medical Device Classification
Medical Device Classification and Certification. Devices used in the treatment of neurovascular, cardiovascular, othopaedic disorders and product devlopment history
European Regulatory Environment
European Regulations, European Medical Devices Vigilance system, Overview of 93/42/EEC, 2001/83/EC and 2007/47/ECMedical Device Directives, revised Medical Device Regulation (MDR) due 2016, in-vitro diagnostic directive 98/79/EC, ISO 13485.
US regulatory Environment
Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Codes of Federal Regulation Title 21-800, US Perspective: Classification and Medwatch Regulatory Agencies, Post approval studies, Investigational Device Exemptions.
Standards Organisations
Review of the key international organisations driving medical device standards development. (CEN, ISO, EN, BSI, ASME, ANSI, JIS, DIN)
Ethical Codes
Review ethical codes from: the Irish Medical device association, Medtech Europe, EUCOmed, Healthcare Products Regulatory Association.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 50 |
| Other Assessment(s) | 50 |