MEC8056 : Medical Devices Regulatory Requirements
- Offered for Year: 2026/27
- Module Leader(s): Dr Jennifer Olsen
- Lecturer: Dr Ilke Turkmendag, Dr Sylvia de Mars
- Owning School: Engineering
- Teaching Location: Newcastle 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 | 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 |
| Scheduled Learning And Teaching Activities | Lecture | 11 | 1:00 | 11:00 | Lectures on remaining course material, aside from main case studies. |
| Structured Guided Learning | Academic skills activities | 1 | 0:30 | 0:30 | Formative assessment - online quiz (30 minutes), |
| Structured Guided Learning | Academic skills activities | 9 | 3:00 | 27:00 | Guided critical reading activities related to the lecture material. |
| 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 introduce key regulatory frameworks and provide the foundational knowledge required for critical evaluation of medical device regulation. Case study-based teaching enables students to apply theoretical knowledge to real-world scenarios, supporting the development of analytical and evaluative skills.
Structured guided learning activities develop students’ ability to engage critically with contemporary regulatory issues through directed reading and independent research. Independent study supports the development of self-directed learning and critical reflection.
These approaches collectively support the development of knowledge and skills aligned with programme outcomes: M2, M4, M6, M7, M8, M11, and M17.
Assessment Methods
The format of resits will be determined by the Board of Examiners
Exams
| Description | Length | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|---|
| Digital Examination | 90 | 2 | A | 80 | Closed-book Inspera digital assessment covering whole syllabus. (M2, M4, M5, M6, M7, M8, M17) |
Other Assessment
| Description | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|
| Oral Presentation | 2 | M | 20 | A group presentation (approx. 4-5 members) covering the group’s solution to a contemporary issue/case study within the field of medical device regulation (M16). |
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, M5, M7, M8, 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, M5, M7, M8 and M17. The group presentation allows students to learn about a case study in-depth, helping them learn beyond the scope of the taught material of the course, whilst also working effectively in a team (M16).
An online quiz of 30 minutes set as a formative assessment provides students the opportunity to determine their level of knoweldge from lecture material and helps guide thier ongoing learning and revision.
Reading Lists
Timetable
- Timetable Website: www.ncl.ac.uk/timetable/
- MEC8056's Timetable