Short Title:Medical Device Regulatory Affairs
Full Title:Medical Device Regulatory Affairs & Ethics
Language of Instruction:English
Module Code:RGAF H3000
 
Credits: 5
NFQ Level:8
Field of Study:Engineering, Manufacturing and Construction
Module Delivered in no programmes
Reviewed By:FIONA CRANLEY
Module Author:ANTHONY TANSEY
Module Description: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.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the medical device industry, the principle regulatory authorities involved.
LO2 Describe the key principles associated with the control and regulation of the medical devices industry.
LO3 Describe specific standards and how they relate to the manufacture of bio-medical devices.
LO4 Describe the key aspects of ethical codes relating to medical devices
LO5 Relate the approvals process and ethical issues of medical device design to a non technical or multidisciplinary audience.
Pre-requisite learning
Co-requisite Modules
No Co-requisite modules listed
 

Module Content & Assessment

Content (The percentage workload breakdown is inidcative and subject to change) %
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).
10.00%
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).
10.00%
Medical Device Classification
Medical Device Classification and Certification. Devices used in the treatment of neurovascular, cardiovascular, othopaedic disorders and product devlopment history
10.00%
European Regulatory Environment
European Regulations, European Medical Devices Vigilance system, Overview of 93/42/EEC, 2001/83/EC and 2007/47/EC Medical Device Directives, revised Medical Device Regulation (MDR) due 2016, in-vitro diagnostic directive 98/79/EC, ISO 13485.
20.00%
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.
20.00%
Standards Organisations
Review of the key international organisations driving medical device standards development. (CEN, ISO, EN, BSI, ASME, ANSI, JIS, DIN)
10.00%
Ethical Codes
Review ethical codes from: the Irish Medical device association, Medtech Europe, EUCOmed, Healthcare Products Regulatory Association.
20.00%
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment The students will be required to investigate the standards and legal requirements for a medical device. The output of this assignment will be a report on the regulatory requirements for the device which identifies the key stages for certification. 1,2,3,4,5 30.00 Ongoing
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 70.00 End-of-Semester
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.
Reassessment Description
Repeat examination and CA if required

IT Tallaght reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 3.00 Every Week 3.00
Lecturer Supervised Learning Application of course material 1.00 Every Week 1.00
Independent Learning Personal study. Research and investigation of related material. 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 3.00 Every Week 3.00
Lecturer Supervised Learning Application of course material 1.00 Every Week 1.00
Assignment Personal study. Research and investigation of related material. 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • [editors] John D. Enderle, Susan M. Blanchard, and Joseph D. Bronzino 2011, Introduction to biomedical engineering, 3rd Ed., Elsevier Academic Press Amsterdam [ISBN: 978-01237497]
  • Seeram Ramakrishna 2015, Medical Devices: Regulations, Standards and Practices, 1st Ed., Woodhead Publishing Ltd [ISBN: 978-008100289]
  • Val Theisz 2015, Medical Device Regulatory Practices: An International Perspective, 1st Ed., Pan Stanford [ISBN: 978-981466910]
  • Mr D G Daugherty 2015, FDA Quality System Regulation for Medical Devices (21 CFR Part 820), CreateSpace Independent Publishing Platform [ISBN: 978-152284024]
This module does not have any article/paper resources
This module does not have any other resources