Module - MATS4011 - Medical Device Regulation

Curriculum Mapping System

Year 2026/27

Main Menu

Home

Overview

Module - MATS4011 - Medical Device Regulation

Programme	M3 - Department of Mechanical, Materials and Manufacturing Engineering modules (Year 4)
Year	Select a new weight: https://curriculum.nottingham.ac.uk/2026/view/tree/1162/year_lookup/XXIDXX Year 2026/2027
Accrediting Bodies	https://curriculum.nottingham.ac.uk/2026/view/tree/1162/year_lookup/XXIDXX Accrediting Body Complete Outcome Set (UK-SPEC, EAC, etc.) Board of Engineers Malaysia Engineering Accreditation Board BEng Engineering Accreditation Board MEng Institution of Engineering Designers (IED) Institution of Mechanical Engineers (IMechE) Institution of Technology (IET)
Module Code	MATS4011
Lecturer	Alastair Campbell-Ritchie

This module covers the International Standards governing the manufacture, testing and performance of medical devices, and the laws regulating the sale of medical devices. The course covers general aspects of standardisation and regulation but has a particular focus on the regulations in force in the European Union. Students should achieve an understanding of the legal aspects governing the design, commercialisation, and marketing of medical devices.

Sessions
Learning Activities
Outcomes
Other Modules

Search:		Reset

No Group
	LO1 - Specify the relevant standards governing the manufacture or testing of a particular medical device. Standards covered in this course include those for medical devices such as prosthetic hips, dialysers, and oxygenators, as well as the standards covering the composition of alloys, and biological safety in cleanrooms, laboratories and manufacturing facilities.
	LO2 - Understand the need for, and benefits of, standardisation and regulation in the field of medical devices. This particularly applies to the consumer/patient protection aspects of standardisation and regulation.
	LO3 - Describe the process by which a medical device is brought to market. Specifically, this applies to the European Union Regulatory framework: 90/385/EEC regarding active implantable medical devices; 93/42/EEC regarding medical devices; 98/79/EC regarding in vitro diagnostic medical devices. Students must describe the roles performed by the manufacturer, the notified body, and the regulatory authority.
	LO4 - Perform a risk/benefit analysis to compare two or more treatment modalities. Students are typically presented with two alternative treatments for a particular condition and are asked to calculate the costs associated with each treatment, including hospital/outpatient care as well as the cost of the treatment itself, and conclude which is most beneficial.
	LO5 - Demonstrate their understanding of the medical device regulations by giving a presentation on either the medical device directive or the active implantable medical device directive.
	LO6 - Demonstrate their understanding of risk management in medical devices, and the process of reducing the risk to the users (practitioners and patients) by designing the risk away, or mitigating the risk through training, labelling and education.

LO1 - Specify the relevant standards governing the manufacture or testing of a particular medical device.

LO2 - Understand the need for, and benefits of, standardisation and regulation in the field of medical devices. This particularly applies to the consumer/patient protection aspects of standardisation and regulation.

LO3 - Describe the process by which a medical device is brought to market. Specifically, this applies to the European Union Regulatory framework:

LO4 - Perform a risk/benefit analysis to compare two or more treatment modalities.

LO5 - Demonstrate their understanding of the medical device regulations by giving a presentation on either the medical device directive or the active implantable medical device directive.

LO6 - Demonstrate their understanding of risk management in medical devices, and the process of reducing the risk to the users (practitioners and patients) by designing the risk away, or mitigating the risk through training, labelling and education.