MEC8056 : Medical Devices Regulatory Requirements
MEC8056 : Medical Devices Regulatory Requirements
- Offered for Year: 2025/26
- 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 | |
Pre-requisite
Modules you must have done previously to study this module
Pre Requisite Comment
N/A
Co-Requisite
Modules you need to take at the same time
Co Requisite Comment
N/A
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 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.
Learning Outcomes
Intended Knowledge Outcomes
By the end of this module, a student will:
Understand relevant legal systems applicable to medical devices (M15)
Analyse the regulatory process where a recent medical device might have been seen to have failed (M4)
Understand the wider societal impact of failed medical devices (M7, M8)
Intended Skill Outcomes
By the end of the module, it is expected that a student will be able to:
• Critique the regulatory framework in which contemporary medical devices are brought to market (M2, M4, M14, M15)
• Evaluate a contemporary medical device which has ‘failed’ and show appreciation of the drivers behind, and thus the claimed recent improvements in, medical device regulation (M2, M4, M6)
• Understand how a failed medical device has wider societal, ethical, legal and EDI implications (M8, M11)
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 | 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 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)
Reading Lists
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, featuring a mix of multiple choice questions and open questions. (M2, M4, M6, M7, M8, M14, M15). |
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, M8, M14, M15). |
Assessment Rationale And Relationship
The Inspera digital exam will assess theoretical understanding of all aspects of the module. The students should be able to apply a broad range of knowledge to the contemporary medical device regulations. The formative assessment will help students to prepare for their summative examination, by reinforcing key concepts related to taught material covered during lectures (M2, M4, M6, M7, M8, M14, M15).
Timetable
- Timetable Website: www.ncl.ac.uk/timetable/
- MEC8056's Timetable
Past Exam Papers
- Exam Papers Online : www.ncl.ac.uk/exam.papers/
- MEC8056's past Exam Papers
General Notes
N/A
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Disclaimer
The information contained within the Module Catalogue relates to the 2025 academic year.
In accordance with University Terms and Conditions, the University makes all reasonable efforts to deliver the modules as described.
Modules may be amended on an annual basis to take account of changing staff expertise, developments in the discipline, the requirements of external bodies and partners, staffing changes, and student feedback. Module information for the 2026/27 entry will be published here in early-April 2026. Queries about information in the Module Catalogue should in the first instance be addressed to your School Office.