Medical Technology Regulatory Affairs Module Details

Module Details (MSc Medical Technology Regulatory Affairs)

Year 1 (30 credits)

Introduction to EU Medical Technology Regulatory Affairs

Year 1:         Semester 1      Credits: 5      Module Director:  TBC

The 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

1. Demonstrate they have detailed knowledge and understanding of the main EU 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. Demonstrate they have 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. Demonstrate they have detailed knowledge and understanding of 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

Introduction to US Medical Technology Regulatory Affairs

Year: 1          Semester 1      Credits: 5      Module Director:  TBC

The 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 US.  It explains the legislation applicable and guidelines available to medical device manufacturers.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the US FDA administrative and legislative structure (FD&C Act) and requirements
2. Source and interpret regulations and guidance documents currently applicable to medical device classification within the US and demonstrate ability to classify devices appropriately
3. Critique FDA guidance documents, consensus standards, FDA forms etc.
4. Illustrate an understanding of the steps required to achieve market clearance/approval for a US destined medical device including all aspects and types of 510(k), PMA, IDE and De Novo applications
5. Analyze requirements for device registration, device listing and establishment registration and post market surveillance requirements once a product is placed on the market

Technical Report Writing

Year: 1          Semester 1      Credits: 5      Module Director: TBC

Technical Report Writing teaches the participant not only the critical techniques a scientist needs to know when conducting research but also how to write about his or her work.  Not only is this relevant for a dissertation and assignments but also for generating formal reports such as clinical evaluation reports.  

Professionals in industry require the skills to share their work with others, to communicate their learning, their discoveries and their failures, thus improving research and thus benefiting the industry as a whole, and more importantly, the patient.

Learning Outcomes

1. Appreciate the nature and importance of technical report writing and review in industry
2. Evaluate the suitability of research methodologies for the purpose of undertaking research
3. Conduct and synthesise an academic literature search relevant to a proposed dissertation or topic
4. Present the research findings in a critically reflective manner which acknowledges the limitations of the research methods
5. Critically review the ethical issues involved in the undertaking of clinical research
6. Formulate and compare methods for data analysis and the presentation of results and compare different methods when presenting different results
7. Present a comprehensive dissertation proposal

Introduction to Global Medical Technology Regulatory Affairs

Year: 1          Semester 2      Credits: 5      Module Director:  TBC

 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 outside of the US and EU, specifically Russia/CiS; Brazil/Latin America; Canada/Australia. It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.

 Learning Outcomes

1.  Demonstrate they have detailed knowledge and understanding of the administrative and legislative structure and requirements for medical devices in key global markets to include Russia/CIS; Brazil/Latin America; Canada/Australia
2. Identify key differences between these regulatory systems and that of the EU and US and outline methodology to ensure a device can utilize key documentation from EU and US applications in achieving market approval in the above defined jurisdictions
3. Critique guidance, directives and legislation currently regulating medical device classification within these global markets and demonstrate ability to classify devices appropriately
4. Articulate an understanding of how to define the regulatory pathway for medical devices in these global markets including complex combination or novel devices
5. Demonstrate they have detailed knowledge and understanding of how to manage change control from a global point of view
6. Source and interpret reimbursement requirements

Clinical Evaluation

Year: 1         Semester 2      Credits: 5      Module Director:  TBC

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

1. Demonstrate they have detailed knowledge and understanding of the key clinical terms, types of studies, key clinical requirements and associated standards
2. Source and interpret, regulations, standards and guidances on how clinical requirements in chosen markets are achieved
3. Critique the role of human factors studies and the impact of risk assessment
4. Demonstrate an ability to prepare documentation associated with clinical evaluations
5. Demonstrate they have detailed knowledge and understanding of clinical investigations application process and reimbursement
6. Illustrate an ability to prepare regulatory submissions and clinical trial applications
7. Formulate and communicate a competency in how to complete a full clinical evaluation plan, which will include objectives, methodology and literature searching processes and resulting clinical evaluation report including format, contents and layout
8. Demonstrate an ability to prepare a clinical evaluation report
9. Identify the interaction between risk analysis and clinical evaluation
10. Evaluate and assess a medical device to determine what, if any, clinical studies are required based upon a critical review of existing data for comparable medical devices (consider strategy development, investigation design and clinical evaluation context)

Quality Management System

Year: 1          Semester 2      Credits: 5      Module Director:  TBC

 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 US. It explains the legislation applicable and guidelines available to medical device manufacturers.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of how a medical device is designed,developed and manufactured in line with 20 CFR 820 and ISO13485
2. Source and interpret ISO13485, CFR 820 and various other relevant standards
3. Understand and evaluate the key elements of 21 CFR 820 including but not exclusive to Quality Management System, Management responsibility, Resource Management, Product Realization, Measurement Analysis and Improvement
4. Demonstrate they have detailed knowledge and understanding of a QMS as specified by CFR820
5. Illustrate a thorough understanding of the underlying principles involved in regulatory compliance, the importance of auditing, best practice on dealing with auditors, Supplier and vendor approach, audit programme, preparation, audit management, dealing with regulatory agencies , audit response process, internal quality standards communication, effective line clearance, training, process flow charts, Part 11 compliance etc.
6. Conduct a systematic and independent examination of the effectiveness of a quality system or of its parts an demonstrate an awareness of the importance of auditor training and the internal auditing programme and how to deal with unannounced audits
7. Formulate and communicate an ability to implement quality and technical agreements
8. Demonstrate they have a detailed knowledge and understanding of the required actions to release product post regulatory approval
9. Demonstrate they have detailed knowledge and understanding of the regulatory role and requirements throughout the product development process

Year 2 (30 credits)

EU Medical Technology Regulatory Affairs Advanced

 Year 2:         Semester 1      Credits: 5      Module Director:  TBC

 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

1.  Demonstrate they have detailed knowledge and understanding of how to manage change control from a EU regulatory perspective throughout the entire medical device lifecycle
2. Demonstrate they have detailed knowledge and understanding of how to define the regulatory pathway for medical devices including complex combination or novel devices and devise appropriate regulatory strategies for a number of theoretical devices
3. Demonstrate they have detailed knowledge and understanding of the submission types involved by completion of mock technical documentation from classification through to commercialisation
4. Demonstrate they have detailed knowledge and understanding of CE Mark renewal process and Directive 98/79/EC
5. Demonstrate they have detailed knowledge and understanding of additional country specific requirements prior and post placement on market
6. Source and interpret reimbursement requirements in each member state

US Medical Technology Regulatory Affairs Advanced

Year: 1         Semester 1      Credits: 5      Module Director:  TBC

 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 US, the essential requirements of devices and submission types & emerging technologies.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the submission types involved by completion of mock submission documentation from classification through to commercialization
2. Formulate and communicate judgements with regard to regulatory decision making process for devices and demonstrate ability to interact effectively with FDA agents
3. Analyse and evaluate data from US FDA MAUDE (Manufacturer and user facility device experience) database
4. Demonstrate they have detailed knowledge and understanding of how to manage change control for a product destined for US market
5. Source and interpret relevant reimbursement

 Risk Management, Labelling & Promotion

Year 2:         Semester 1      Credits: 5      Module Director:  TBC

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 labelling, sale and supply regulatory requirements for medical devices. The module also covers the application of risk management to medical devices.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the content and application of ISO 14971: Medical devices - application of risk management to medical devices & risk management planning and the key components of a risk management file
2. Implement a risk management plan including risk analysis, risk evaluation, implemetation of appropriate risk controls and conduct a risk/benefit analysis
3. Communicate they have a detailed knowledge and understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, label / IFU review best practice , elabelling
4. Demonstrate they have a detailed knowledge and understanding of the legislation and regulations associate with medical device advertising and promotion from EU/US and Gobal perspective and also country specific requirements
5. Communicate a detailed knowledge of context of off label use/on label use and particular requirements for website content
6. Evaluate the relevance of social media (twitter, blogs..) and future directions for advertising and promotion. Evaluate the place of physician /customer contact and direct to consumer advertising in promotion strategy
7. Formulate and communicate judgements from a regulatory standpoint in each step of the risk management process and demonstrate ability to interact effectively with regulatory agents

 Global Medical Technology Regulatory Affairs Advanced

Year 2:         Semester 2      Credits: 5      Module Director:  TBC

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 outside of the US and EU, specifically China, Japan, SE Asia (Taiwan/Korea etc). It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the administrative and legislative structure and requirements for medical devices in key global markets to include but not limited to China, Japan, SE Asia (Taiwan/Korea etc)
2. Identify key differences between these regulatory systems and that of the EU and US and outline methodology to ensure a device can utilize key documentation from EU and US applications in achieving market approval in the above defined jurisdictions
3. Source and interpret guidance, directives and legislation currently regulating medical device classification within these global markets and demonstrate ability to classify devices appropriately
4. Source and interpret local global market standards
5. Demonstrate they have detailed knowledge and understanding of how to define the regulatory pathway for medical devices in these global markets including complex combination or novel devices
6. Demonstrate they have detailed knowledge and understanding of how to achieve market clearance/approval for a medical device destined for a global marketplace and how to address post market surveillance requirements once a product is placed on the market
7. Demonstrate they have detailed knowledge and understanding of the submission types involved by completion of mock technical documentation from classification through to commercialization
8. Formulate and communicate judgements with regard to regulatory issues for devices such as country specific nuances connected with entry/exit from each country and demonstrate ability to interact effectively with appropriate authorities
9. Demonstrate they have detailed knowledge and understanding of how to manage change control from a global point of view
10. Source and interpret reimbursement requirements

Design Assurance, Sterilisaton and Biocompatability

Year: 2        Semester 2      Credits: 5      Module Director:  TBC

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 design assurance process, common sterilization techniques for medical devices, associated standards and validation. It aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.

Learning Outcomes

1. Demonstrate an ability to develop verifiable design inputs and understand the links to risk management activities
2. Demonstrate an ability to design a test protocol including risk based acceptance criteria, sample sizes and use of appropriate statistical methods
3. Develop a test report strategy and demonstrate ability to generate reports
4. Critically assess the use of standard and non standard test reports
5. Demonstrate they have a detailed knowledge and understanding of the common sterilization techniques for medical devices
6. Source and interpret procedures and standards currently regulating medical device sterilization and validation requirements
7. Source and interpret ISO10993 1 for evaluation of the biocompatibility of medical devices. Apply classification of the device as outlined in the standard
8. Demonstrate an understanding of the common biocompatibility testing methods and interpretation of the test results
9. Formulate and communicate an understanding of the rationale and benefit of product characterization
10. Evaluate sterilization methods under various headings to include packaging, products effects, costs etc
11. Formulate and communicate an ability to generate biocompatibility reports to meet regulatory requirements

 Post Market Surveillance

Year: 2         Semester  2      Credits: 5      Module Director:  TBC

This module is taken by Level 9 students in Medical Technology Regulatory Affairs and it aims to provide students with a detailed knowledge and understanding of post market requirements for medical devices. Specifically this module aims to develop the student’s ability to create and implement a comprehensive post market surveillance plan to collect, evaluate and respond to data on device safety and performance after market approval.

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of global statutory reporting requirements including local interpretation and current expectations with particular emphasis on EU and US requirements
2. Demonstrate they have detailed knowledge and understanding of post market surveillance requirements and development of a post market surveillance plan that is consistent with the risk associated with the device based on its intended use
3. Demonstrate they have detailed knowledge and understanding of complaint management including assessment, evaluation and response to post market data
4. Demonstrate they have detailed knowledge and understanding of risk management principles and requirements including the role of detailed risk assessment in the evaluation and response to post market data
5. Demonstrate they have detailed knowledge and understanding of requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls. This shall include an understanding of the critical components of effective field action management
6. Understand the links between CER and risk management and other documentation to proactively incorporate these into routine post market surveillance activities
7. Analyse and evaluate post market surveillance data within a risk management process to achieve a lower risk/better product, e.g. data from US FDA MAUDE (Manufacturer and user facility device experience) database
8. Formulate and communicate a post marketing surveillance strategy which meets appropriate regulatory requirements