REGU09001 2019 Introduction to EU Medical Technology Regulatory Affairs

General Details

Full Title
Introduction to EU Medical Technology Regulatory Affairs
Transcript Title
Introduction to EU Medical Tec
Code
REGU09001
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ 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_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology 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. It explains the legislation applicable and guidelines available to medical device manufacturers.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate they have detailed knowledge and understanding of the new EU regulations i.e. MDR and IVDR, the MDD, AIMD and IVD directives and their context within the EU legislative framework.

2.

Source and interpret the applicable New Approach directives (MDD, AIMD and IVD )and the new EU medical device regulations i.e. MDR and IVDR regulating medical device classification within the EU and demonstrate ability to classify devices, including complex combination or novel devices appropriately.

3.

Illustrate detailed knowledge and understanding of the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority under the current medical device directives and the MDR and IVDR.

4.

Demonstrate they have a knowledge and understanding of conformity assessment procedures under the current medical device directives and the MDR and IVDR.

5.

Source and interpret ISO13485 and various other relevant standards and guidance documents e.g. MDCG documents. MEDDEVS, NB-MEDS, GHTF guidance

6.

Describe the essential requirements of the medical device directives and the General Safety and Performance Requirements of the MDR and IVDR and how a manufacturer will address and meet each  requirement as applicable.

7.

Identify appropriate regulatory pathways the submission types involved in the EU regulatory system.

8.

Develop strategies to address change control, understand the process of Change Assessment and RA Determinations. Overview of types of Regulatory body notifications and Technical File updates.

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: EU regulations, medical device legislation; relevant standards, regulatory pathway; classification.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment written assignment Continuous Assessment Assignment 45 % Week 12 1,2,3,4,5,6,7,8
2 short essay Continuous Assessment Essay 15 % Week 11 8
3 Webinar review - blog Continuous Assessment Assessment 5 % Week 7 6
4 Case Study/essay(formative) Continuous Assessment Assessment 20 % Week 6 4,5,6
5 SAQ Continuous Assessment Open Book Exam 5 % Week 3 1,2,3,7
6 E-activity review of available white papers Continuous Assessment Assignment 10 % Week 4 1,2,3

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

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

HPRA website

Europa Website

Key Notified Body white papers

White papers from key medical device groups e.g. RAPs, TOPRA 
IMDRF website
Key Webinars

Other Resources

None

Additional Information

None