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MEC8056 : Medical Devices Regulatory Requirements

  • Offered for Year: 2024/25
  • Module Leader(s): Professor Tom Joyce
  • Lecturer: Dr Ilke Turkmendag, Dr Sylvia de Mars
  • Owning School: Engineering
  • Teaching Location: Newcastle City Campus

Your programme is made up of credits, the total differs on programme to programme.

Semester 2 Credit Value: 20
ECTS Credits: 10.0
European Credit Transfer System


• 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 and societal impact.

• Raise critical awareness of regulatory aspects relevant to medical devices.

Outline Of Syllabus

Definitions of a medical device

Case studies of recent medical devices where the regulatory process may have failed.

Different national and international medical device regulatory systems.

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion150:0050:00Preparation and completion of work around the individual assignment and computer examination.
Scheduled Learning And Teaching ActivitiesLecture61:006:00Lectures on remaining course material, aside from case studies
Scheduled Learning And Teaching ActivitiesLecture32:006:00Two-hour lectures to introduce case studies.
Structured Guided LearningAcademic skills activities93:0027:00Guided critical reading activities around each lecture.
Scheduled Learning And Teaching ActivitiesDrop-in/surgery41:004:00Open office to allow students to come and ask any questions
Guided Independent StudyIndependent study1106:00106:00Independent Study
Scheduled Learning And Teaching ActivitiesModule talk11:001:00Induction 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 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 assignment, 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 Examination452A50Digital assessment covering whole syllabus.
Other Assessment
Description Semester When Set Percentage Comment
Written exercise2M501000 words maximum
Formative Assessments

Formative Assessment is an assessment which develops your skills in being assessed, allows for you to receive feedback, and prepares you for being assessed. However, it does not count to your final mark.

Description Semester When Set Comment
Computer assessment2MRegular 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 assignment 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 assignment 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