REGU09007 2019 EU Medical Technology Regulatory Affairs- Advanced
Full Title
EU Medical Technology Regulatory Affairs- Advanced
Transcript Title
EU Medical Technology Regulato
Code
REGU09007
Attendance
N/A %
Subject Area
REGU - 0421 Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Medical Device Regulatory Affairs
SG_SMEDI_M09 201900 Master of Science in Medical Technology Regulatory Affairs
SG_SMEDI_C09 202100 Postgraduate Certificate in Medical Device Regulatory Affairs
Description
This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the EU, the essential requirements of devices and submission types & emerging technologies.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate detailed understanding and knowledge of the new European Medical Device Regulations (MDR) and In vitro diagnostics Regulation (IVDR)
2.
Define the regulatory pathway for medical devices and different submission types to get a device to market and to obtain CE approval including ISO13485:2016
3.
Understand how to carry out a gap analysis on your regulatory system
4.
Demonstrate understanding of notified body and county specific competent authority roles across Europe and the responsibilities of these bodies
5.
Critique and evaluate the political, strategic, logistical, manufacturing; landscape effects in Europe on the medical device industry in terms of new legislation; changing standards and guidances; device issues in the media, political changes in Europe.
Teaching and Learning Strategies
The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.
Module Assessment Strategies
The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.
Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos
Repeat Assessments
The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.
Indicative Syllabus
The following is a summary of the main topics included in this particular module: classification; essential requirements; future directives, MEDDEVS, NB Meds, Competent Authorities, Notified Bodies, Authorised Reps, Change Control. Emerging technologies.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Assignment written assignment | Coursework Assessment | Assignment | 60 % | Week 8 | 1,3,5 |
| 2 | Case Study workshop scenarios (formative) | Coursework Assessment | Assessment | 20 % | Week 12 | 4,5 |
| 3 | LAQ | Coursework Assessment | Open Book Exam | 20 % | Week 5 | 1,2,3,4 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Recommended Reading
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164
The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.
Module Resources
Non ISBN Literary Resources
www.hpra.ie
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Directive 98/79/EC
Europa website re medical devices:
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Irish Competent Authority (HPRA) website:
https://www.hpra.ie/homepage/medical-devices/regulatory-information
Journal Resources
www.hpra.ie
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Directive 98/79/EC
Europa website re medical devices:
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Irish Competent Authority (HPRA) website:
https://www.hpra.ie/homepage/medical-devices/regulatory-information
URL Resources
www.hpra.ie
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Europa website re medical devices:
http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm
Irish Competent Authority (HPRA) website:
https://www.hpra.ie/homepage/medical-devices/regulatory-information
Other Resources
List of Meddevs and NBOGs: http://www.meddev.info/
Additional Information
None