REGU09001 2019 Introduction to EU Medical Technology Regulatory Affairs

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.

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.

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.

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

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

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.

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

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.

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.

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

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.

The following is a summary of the main topics included in this particular module: EU regulations, medical device legislation; relevant standards, regulatory pathway; classification.