MEC8056 : Medical Devices Regulatory Requirements
- Offered for Year: 2019/20
- Module Leader(s): Professor Tom Joyce
- Lecturer: Dr Semande Ayihongbe, Dr Ilke Turkmendag Brunsnes
- Owning School: Engineering
- Teaching Location: Newcastle City Campus
|Semester 2 Credit Value:||20|
• 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 in terms of regulations; clinical trials, efficacy and safety
• 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
• The US regulatory system for medical devices: FDA, 510k, PMA, HDE, MAUDE
• Other regulatory systems: Australia, India, China
• Future challenges in the regulations of medical devices including combination products and apps
• Individual project work on a contemporary issue in regulation of medical devices
|Guided Independent Study||Assessment preparation and completion||24||0:30||12:00||N/A|
|Guided Independent Study||Assessment preparation and completion||1||1:00||1:00||N/A|
|Scheduled Learning And Teaching Activities||Lecture||24||1:00||24:00||N/A|
|Guided Independent Study||Reflective learning activity||1||50:00||50:00||N/A|
|Guided Independent Study||Independent study||1||65:00||65:00||N/A|
|Guided Independent Study||Independent study||24||2:00||48:00||N/A|
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. These case studies will be assessed and critiqued by students during class based discussions, prior to one of them being examined in an individual essay. In addition, through an online computer examination, taught course material will be assessed. Private study supports the students' self-study in reading around the lecture material and the associated scientific literature.
The format of resits will be determined by the Board of Examiners
|PC Examination||60||2||A||50||PC Examination of taught material|
|Essay||2||M||50||2000 words maximum to appraise a contemporary medical device 'scandal' in terms of the medical device regulation available.|
Assessment Rationale And Relationship
Half (50%) of the assessment will be by PC examination where knowledge of the taught material will be assessed.
The remaining 50% of 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.
For the purposes of professional body accreditation, in order to obtain a passing mark overall for this module (50%) at the first attempt the minimum acceptable mark for each of the assessment items specified above shall be 35%, with the maximum possible module overall mark where this is not the case being restricted to 40%.