Full Title Introduction to EU Medical Technology Regulatory Affairs

Short Title EU MedTech RA Intro

Code REGU09001
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

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.

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.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of the main EU regulations, directives and their context within the EU legislative framework, including Directive 98/79/EC

  2. Source and interpret medical device directives currently 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

  4. Demonstrate they have detailed knowledge and understanding of current conformity assessment procedures.

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

  6. Describe the essential requirements of each device and how a manufacturer will address and meet each essential requirement.

  7. Identify the submission types involved in the EU regulatory system.


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

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 4,5,6,7 60 Week 6
Case Study workshop scenarios (formative) 5,7 20 Week 12
LAQ 1,2,3 20 Week 3


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
Url 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
Additional Info

ISBN BookList

Book Cover Book Details
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164