Postgraduate

MEC8056 : Medical Devices Regulatory Requirements

Semesters
Semester 2 Credit Value: 20
ECTS Credits: 10.0

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, 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

Future challenges in medical device regulation

Teaching Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

Teaching Activities
Category Activity Number Length Student Hours Comment
Scheduled Learning And Teaching ActivitiesLecture32:006:00[PiP] Two-hour lectures to introduce case studies.
Scheduled Learning And Teaching ActivitiesLecture61:006:00[Non-essential PIP] Lectures on remaining course material, aside from case studies
Guided Independent StudyAssessment preparation and completion150:0050:00Preparation and completion of work around the individual assignment
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
Total200:00
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.

Alternative online sessions will be offered to students if in-person sessions are not possible (due to unforeseen circumstances such as a pandemic). In that case, Lectures can be placed online as non-synchronous taught material. The drop-in sessions can become synchronous online.

Assessment Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

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

Other Assessment
Description Semester When Set Percentage Comment
Essay2M1002500 words maximum
Assessment Rationale And Relationship

The assessment will consist of 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.

Reading Lists

Timetable