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Module

MEC8056 : Medical Devices Regulatory Requirements

  • Offered for Year: 2020/21
  • Module Leader(s): Professor Tom Joyce
  • Lecturer: Dr Semande Ayihongbe, Dr Ilke Turkmendag, Dr Sylvia de Mars
  • Owning School: Engineering
  • Teaching Location: Newcastle City Campus
Semesters
Semester 2 Credit Value: 20
ECTS Credits: 10.0

Aims

• Introduce the importance of regulatory requirements to medical devices.
• Provide knowledge and understanding of key medical devices, as case studies, which have come to market and yet have led to significant patient concerns, namely breast implants, mesh implants and metal-on-metal hips.
• Raise critical awareness of regulatory aspects relevant to medical devices, namely: different international regulators, notified bodies, CE marking, pre-clinical testing, technical dossiers, EU Medical Device Regulations and post-market surveillance.

Outline Of Syllabus

• What is a medical device, definitions and difference between a medical device and a medical implant
• Difference between medical devices and medicines in terms of regulations; clinical trials, efficacy and safety
• Case studies of recent medical devices where the regulatory process may have failed: PiP breast implants, vaginal mesh implants and ASR metal-on-metal hips
• The European regulatory system for medical devices: MDR 2017/745, CE marking, notified bodies, competent authorities, EUDAMED
• The UK regulatory system: MHRA, NICE, HTAs
• The US regulatory system for medical devices: FDA, 510k, PMA, HDE, MAUDE
• Future challenges in the regulations of medical devices including combination products and apps
• Individual project work on a contemporary issue in regulation of medical devices

Teaching Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

Teaching Activities
Category Activity Number Length Student Hours Comment
Structured Guided LearningLecture materials181:0018:00Non-Synchronous - Structured presentation of module material
Guided Independent StudyReflective learning activity130:0030:00For the assignment
Guided Independent StudyIndependent study1116:00116:00Reading around the subject and understanding background issues
Guided Independent StudyIndependent study182:0036:00Review of lecture material
Total200:00
Teaching Rationale And Relationship

Lectures will introduce the teaching material, which will cover contemporary medical device regulation in various countries to indicate the global need for and reach of medical device regulation. Beginning with identifying what defines a medical device, the lecture material will go on to describe different classes of implants and the various risk levels that frame these classes. Teaching material will then cover important differences between regulations applicable to medical devices and medicines, investigating why such differences exist. Teaching material will then introduce three recent, large-scale ‘scandals’ involving medical devices and, through these taught case studies, analyse in detail issues and potential improvements to medical device regulation. One of these case studies will be assessed in an individual essay, which will also require context to be explained and thus evaluate student's understanding of taught course material. Private study supports the students' self-study in reading around the lecture material and the associated scientific literature.

Assessment Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Essay2M1002500 words maximum
Assessment Rationale And Relationship

The assessment will consist of an individual essay which tests the student’s ability to appraise the scientific literature on a contemporary ’scandal’ regarding medical device regulation and thus the areas in which improvements have been, or could be, made. The essay will also require context to be described and thus knowledge of the taught material will be assessed.
For the purposes of professional body accreditation, in order to obtain a passing mark overall for this module (50%) at the first attempt the minimum acceptable mark for each of the assessment items specified above shall be 35%, with the maximum possible module overall mark where this is not the case being restricted to 40%.

Reading Lists

Timetable