| CODE | ENR5201 | |||||||||
| TITLE | Medical Device Certification | |||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | |||||||||
| ECTS CREDITS | 5 | |||||||||
| DEPARTMENT | Faculty of Engineering | |||||||||
| DESCRIPTION | Regulation has a massive impact on the design of medical devices, especially with respect to high-risk products such as implantable and imaging medical devices. Regulation lays out the requirements which medical device manufacturers will need to meet in order to demonstrate that their product has been designed to be clinically safe and perform as intended in the field. In this study-unit, we intend to provide students with an overview of how medical devices are regulated, and provide insight into how regulation affects device design. It is imperative that biomedical engineers have a solid foundation in regulation to allow them to design safe and effective medical devices, as well as understand the regulatory requirements incumbent of the medical equipment in your charge. Study-Unit Aims: This study-unit provides the necessary information to students that will be appreciated and understood, mainly by the designers of new medical devices, employees at the hospitals providing the maintenance of the medical equipment, and devices. It provides the basic strategy of the evaluation, approval of each medical device, and the regulations set by the higher authorities at the EU regulatory institution for the medical field. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Define the importance of regulation and apply it to medical devices. - Plan the design, verification, and validation stages of medical device design. 2. Skills: By the end of the study-unit the student will be able to: - Correctly classify medical devices. - Identify the stages of medical device design, in accordance with industry best practice. - Conduct a biological evaluation plan for their medical device, in accordance with ISO 10993-1:2018 and state of the art guidance. - Carry out a risk assessment studies in accordance with ISO 14971:2019. - Develop a clinical evaluation report in accordance with the EU MDR. - Collate and construct an EU MDR-compliant technical file. Main Text/s and any supplementary readings: - EU Medical Device Regulation 2017/745 (MDR). - EU IVD Medical Device Regulation 2017/746 (IVDR). Other European and International Standards may be required, including: - EN ISO 14971. - EN ISO 13485. - EN 60601. - ISO 10993. |
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| STUDY-UNIT TYPE | Lect, Ind Study, Project, Seminar and Tutorial | |||||||||
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
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