REGU08002 2017 Fundamentals of EU Medical Device Regulations

General Details

Full Title
Fundamentals of EU Medical Device Regulations
Transcript Title
EU Med Dev Regs
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_E08 202100 Certificate in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

This module aims to provide students with an introduction to and a fundamental understanding of current and upcoming EU legislation as it applies to medical devices and to provide students with an understanding of the EU classification system and potential regulatory pathways for placing medical devices on the market in the EU. It also aims to provide the students with an understanding of the utilisation of standards and guidance documents (MEDDEVs, NBOGs and NBMEDS).

Learning Outcomes

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


Describe the evolution of current legislation and reasons for upcoming revised legislation


Classify a medical device under EU requirements


Analyse key guidance documents


Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessment routes


Make change control assessments for common change types


Identify the key documents required in technical documentation to support an EU regulatory submission


Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority


Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: 

  • The history of medical device regulation in Europe and the current Medical Device Directives (MDD, AIMD, IVDD) and key players
  • How to determine device classification
  • Outline of regulatory pathways and key submission types
  • How to meet applicable Essential Requirements and assign appropriate conformity assessment routes
  • Fundamental understanding of the requirements for technical documentation
  • How to apply standards and use appropriate guidance documents
  • How to manage change control
  • MDR/IVDR Overview

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 20 % Week 2 2,6,7
2 Essay Continuous Assessment Essay 30 % Week 5 1,2,3,5,8
3 MCQ/LAQ Continuous Assessment Multiple Choice 15 % Week 9 4,5
4 Critical evaluation Continuous Assessment Written Report 25 % Week 7 4,6
5 Presentation Continuous Assessment Oral Exam 10 % Week 12 3,6

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2014-04-29 European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty Springer

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation.

In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

Module Resources

Non ISBN Literary Resources

as per booklist

URL Resources

Directive 98/79/EC

Europa website re medical devices:

Irish Competent Authority (HPRA) website:


Other Resources

as per URLs