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MEC8056 : Medical Devices Regulatory Requirements

  • Offered for Year: 2023/24
  • Module Leader(s): Professor Tom Joyce
  • Lecturer: Dr Ilke Turkmendag, Dr Sylvia de Mars
  • Owning School: Engineering
  • Teaching Location: Newcastle City Campus
Semester 2 Credit Value: 20
ECTS Credits: 10.0


• 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

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, post-Brexit changes, UK CA mark

The US medical device regulatory system: the FDA, 510k, PMA

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Scheduled Learning And Teaching ActivitiesLecture32:006:00[PiP] Two-hour lectures to introduce case studies.
Guided Independent StudyAssessment preparation and completion150:0050:00Preparation and completion of work around the individual assignment and computer examination.
Scheduled Learning And Teaching ActivitiesLecture61:006:00[Non-essential PIP] Lectures on remaining course material, aside from case studies
Structured Guided LearningAcademic skills activities93:0027:00Guided critical reading activities around each lecture.
Scheduled Learning And Teaching ActivitiesDrop-in/surgery41:004:00[PiP] Open office to allow students to come and ask any questions
Guided Independent StudyIndependent study1106:00106:00Independent Study
Scheduled Learning And Teaching ActivitiesModule talk11:001:00[Synchronous online] Induction lecture to introduce the module
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

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

Description Length Semester When Set Percentage Comment
Digital Examination452M50End of module in-class digital assessment covering whole syllabus.
Other Assessment
Description Semester When Set Percentage Comment
Essay2M501000 words maximum
Formative Assessments
Description Semester When Set Comment
Digital Examination2MRegular online quizzes are offered to help reinforce lecture material and guide student learning.
Assessment Rationale And Relationship

The assessment will consist of two parts. First, a computer based, multiple choice question exam covering the material delivered across the whole syllabus. Second, 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. Regular computer-based formative assessments will allow students to test their learning of the taught material.

Reading Lists