MEC8056 : Medical Devices Regulatory Requirements
- Offered for Year: 2026/27
- Module Leader(s): Dr Jennifer Olsen
- Lecturer: Dr Sylvia de Mars, Dr Ilke Turkmendag
- Owning School: Engineering
- Teaching Location: Â鶹´«Ã½ City Campus
Semesters
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 | |
Aims
• To develop critical understanding of regulatory frameworks governing medical devices across international contexts.
• To examine the ethical, societal, and patient safety implications associated with medical device regulation and failure.
• To analyse case studies of medical devices that have led to significant patient concern and regulatory scrutiny.
• To develop the ability to exercise independent judgement in evaluating regulatory decisions and their consequences.
Outline Of Syllabus
• Definitions and classification of medical devices.
• International regulatory frameworks (e.g. UK, EU MDR, FDA).
• Case studies of medical devices where regulatory processes have been challenged or have failed.
• Risk classification, approval pathways, and post-market surveillance.
• Ethical, societal, legal, and EDI implications of medical device regulation and failure.
Teaching Methods
Teaching Activities
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| Scheduled Learning And Teaching Activities | Lecture | 11 | 1:00 | 11:00 | Lectures on remaining course material, aside from main case studies. |
| Scheduled Learning And Teaching Activities | Lecture | 3 | 2:00 | 6:00 | Two-hour lectures to introduce case studies. |
| Scheduled Learning And Teaching Activities | Lecture | 1 | 1:00 | 1:00 | Induction lecture to introduce the module |
| Guided Independent Study | Assessment preparation and completion | 1 | 2:00 | 2:00 | Inspera PC assessment (2h) covering the whole syllabus |
| Structured Guided Learning | Academic skills activities | 9 | 3:00 | 27:00 | Guided critical reading activities related to the lecture material. |
| Structured Guided Learning | Academic skills activities | 1 | 0:30 | 0:30 | Formative assessment - online quiz (30 minutes), |
| Scheduled Learning And Teaching Activities | Drop-in/surgery | 4 | 1:00 | 4:00 | Open office to allow students to come and ask any questions |
| Guided Independent Study | Independent study | 1 | 148:30 | 148:30 | Independent study and preparation for the computer examination. |
| Total | 200:00 |
Teaching Rationale And Relationship
Lectures cover fundamental knowledge and help students to apply what they learnt to specific case studies. Independent study supports the students’ self-study in reading around the lecture material and learning about contemporary issues with medical device regulations. Assessment preparation and completion will allow students to fully prepare for both their formative and summative assessments. (M2, M4, M6, M8, M14, M15)
Assessment Methods
The format of resits will be determined by the Board of Examiners
Exams
| Description | Length | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|---|
| Digital Examination | 120 | 2 | A | 100 | Closed-book Inspera digital assessment covering whole syllabus. (M2, M4, M6, M7, M8, M11, M17) |
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 assessment | 2 | M | An online quiz (30 minutes), offered to help reinforce lecture material and guide student learning (M2, M4, M6, M7, M8, M11, M17). |
Assessment Rationale And Relationship
The inspera digital examination assesses the full range of module content through both structured and open-ended questions requiring students to apply regulatory knowledge, evaluate medical device case studies, and exercise reasoned judgement, thereby supporting achievement of M2, M4, M6, M7, M8, M11 and M17.
Reading Lists
Timetable
- Timetable Website: