{"id":{"repo_id":"dundee","oai_identifier":"oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a"},"canonical_url":"https://search.dev.ndltd.org/etd/dundee/oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a","repository":{"repo_id":"dundee","name":"University of Dundee","base_url":"https://discovery.dundee.ac.uk/ws/oai"},"display":{"title":"Development of UK legislation Guidance for Research Medical and In Vitro Diagnostic Devices","abstract":"Background: Legislation controls the research, design, development and manufacture of medical devices and in vitro diagnostic devices in the United Kingdom (UK) and the European Union (EU). Organisations working in this field can demonstrate their regulatory compliance to this legislation by being accredited to BS EN ISO 13485 – BS EN ISO 13485:2016 ‘Medical devices - Quality management systems - Requirements for regulatory’(1).
The Departments of Medical Physics and Hydatidiform Mole Follow-Up (Scotland) (HMFUS), collectively referred throughout this thesis as M&H, within Ninewells Hospital NHS Tayside are accredited to this standard to allow them to undertake research, design, development and manufacture of medical and in vitro diagnostic devices. This accreditation also enables medical and in vitro diagnostic devices to be European Conformity (CE) marked to the appropriate EU directive or regulation(180).
Aim: The aim of this project is to ensure academics and third parties collaborating with M&H meet the legislative and regulatory requirements for the development of those medical or in vitro diagnostic devices to be placed within a healthcare environment.
Method: A review of the new Medical Device Regulations (MDR)(2), In Vitro Diagnostic Device Regulations (IVDR)(3) and UK Medical Devices Legislation(4), alongside the requirements of the 2016 revision of the BS EN ISO 13485 standard, to ensure the continuing accreditation within M&H. A case study of the research project – ‘the ‘Optical Coherence Elastography’ system, will be undertaken to gain an understanding of the regulatory documentation required.
Results: The development of documentation that must be followed by academics and third parties carrying out research and the devolvement within M&H to ensure their projects meet the requirements of the legislation and BS EN ISO 13485:2016 regulatory requirements. This documentation must also be followed by M&H to ensure their projects meet both the legislative and the regulatory requirements.
Conclusion:
1 That the documentation, required to ensure the work in relation to MDR and IVDR devices meets the regulatory and legislative requirements, has been produced.
2 That this documentation, on being reviewed by external auditors, confirms compliance with BS EN ISO 13485
3 When completed, this documentation will show that the OCE system complies with the legislative exemptions after review.","abstract_html":"<b>Background</b>: Legislation controls the research, design, development and manufacture of medical devices and in vitro diagnostic devices in the United Kingdom (UK) and the European Union (EU). Organisations working in this field can demonstrate their regulatory compliance to this legislation by being accredited to BS EN ISO 13485 – BS EN ISO 13485:2016 ‘Medical devices - Quality management systems - Requirements for regulatory’(1).<br/><br/>The Departments of Medical Physics and Hydatidiform Mole Follow-Up (Scotland) (HMFUS), collectively referred throughout this thesis as M&H, within Ninewells Hospital NHS Tayside are accredited to this standard to allow them to undertake research, design, development and manufacture of medical and in vitro diagnostic devices. This accreditation also enables medical and in vitro diagnostic devices to be European Conformity (CE) marked to the appropriate EU directive or regulation(180).<b><br/></b><b><br/></b><b>Aim</b>: The aim of this project is to ensure academics and third parties collaborating with M&H meet the legislative and regulatory requirements for the development of those medical or in vitro diagnostic devices to be placed within a healthcare environment.<b><br/></b><b><br/></b><b>Method</b>: A review of the new Medical Device Regulations (MDR)(2), In Vitro Diagnostic Device Regulations (IVDR)(3) and UK Medical Devices Legislation(4), alongside the requirements of the 2016 revision of the BS EN ISO 13485 standard, to ensure the continuing accreditation within M&H. A case study of the research project – ‘the ‘Optical Coherence Elastography’ system, will be undertaken to gain an understanding of the regulatory documentation required.<b><br/></b><b><br/></b><b>Results</b>: The development of documentation that must be followed by academics and third parties carrying out research and the devolvement within M&H to ensure their projects meet the requirements of the legislation and BS EN ISO 13485:2016 regulatory requirements. This documentation must also be followed by M&H to ensure their projects meet both the legislative and the regulatory requirements.<b><br/></b><b><br/></b><b>Conclusion</b>:<br/>1 That the documentation, required to ensure the work in relation to MDR and IVDR devices meets the regulatory and legislative requirements, has been produced.<br/>2 That this documentation, on being reviewed by external auditors, confirms compliance with BS EN ISO 13485<br/>3 When completed, this documentation will show that the OCE system complies with the legislative exemptions after review.","abstract_has_math":false,"creators":["Carena, Amedeo Patrizio"],"institution":"University of Dundee","degree_name":"Master of Science","degree_level":"Master's Thesis","degree_discipline":null,"degree_department":null,"school":null,"contributors":[],"advisors":["Huang, Zhihong","Li, Chunhui"],"committee_chairs":[],"committee_members":[],"year":2021,"date_issued":"2021","date_published":"2021","updated_at":"2026-07-24T02:08:59Z","subjects":["Medical Devices Regulations","In Vitro diagnostic Devices Regulations","Medical Qaulity Assurance","13485","9001"],"languages":["eng"],"rights":[],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a"],"render_values":[{"text":"oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a","href":null,"code":true}]}]},"links":{"outbound_url":"https://discovery.dundee.ac.uk/en/studentTheses/4e31417e-50e1-4c22-9030-18ad357bef5a","outbound_label":"Repository record","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor.advisor","label":"Advisor","values":["Huang, Zhihong","Li, Chunhui"]},{"key":"dc:creator","label":"Author","values":["Carena, Amedeo Patrizio"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date","label":"Dc Date","values":["2021"]},{"key":"dc:date.issued","label":"Date","values":["2021"]},{"key":"dc:publisher.department","label":"Dc Publisher Department","values":["Biomedical Engineering"]},{"key":"dc:publisher.institution","label":"Dc Publisher Institution","values":["University of Dundee"]},{"key":"dc:relation.isreferencedby","label":"Dc Relation Isreferencedby","values":["https://discovery.dundee.ac.uk/en/studentTheses/4e31417e-50e1-4c22-9030-18ad357bef5a"]},{"key":"dc:type","label":"Dc Type","values":["Thesis"]},{"key":"dc:type.qualificationlevel","label":"Dc Type Qualificationlevel","values":["Master's Thesis"]},{"key":"dc:type.qualificationname","label":"Dc Type Qualificationname","values":["Master of Science"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Medical Devices Regulations","In Vitro diagnostic Devices Regulations","Medical Qaulity Assurance","13485","9001"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language","label":"Dc Language","values":["eng"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a","https://discovery.dundee.ac.uk/en/studentTheses/4e31417e-50e1-4c22-9030-18ad357bef5a"]},{"key":"dc:identifier.uri","label":"Identifier URI","values":["https://discovery.dundee.ac.uk/files/55179233/Carena_PhD_Thesis_2021.pdf"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["Background: Legislation controls the research, design, development and manufacture of medical devices and in vitro diagnostic devices in the United Kingdom (UK) and the European Union (EU). Organisations working in this field can demonstrate their regulatory compliance to this legislation by being accredited to BS EN ISO 13485 – BS EN ISO 13485:2016 ‘Medical devices - Quality management systems - Requirements for regulatory’(1).
The Departments of Medical Physics and Hydatidiform Mole Follow-Up (Scotland) (HMFUS), collectively referred throughout this thesis as M&H, within Ninewells Hospital NHS Tayside are accredited to this standard to allow them to undertake research, design, development and manufacture of medical and in vitro diagnostic devices. This accreditation also enables medical and in vitro diagnostic devices to be European Conformity (CE) marked to the appropriate EU directive or regulation(180).
Aim: The aim of this project is to ensure academics and third parties collaborating with M&H meet the legislative and regulatory requirements for the development of those medical or in vitro diagnostic devices to be placed within a healthcare environment.
Method: A review of the new Medical Device Regulations (MDR)(2), In Vitro Diagnostic Device Regulations (IVDR)(3) and UK Medical Devices Legislation(4), alongside the requirements of the 2016 revision of the BS EN ISO 13485 standard, to ensure the continuing accreditation within M&H. A case study of the research project – ‘the ‘Optical Coherence Elastography’ system, will be undertaken to gain an understanding of the regulatory documentation required.
Results: The development of documentation that must be followed by academics and third parties carrying out research and the devolvement within M&H to ensure their projects meet the requirements of the legislation and BS EN ISO 13485:2016 regulatory requirements. This documentation must also be followed by M&H to ensure their projects meet both the legislative and the regulatory requirements.
Conclusion:
1 That the documentation, required to ensure the work in relation to MDR and IVDR devices meets the regulatory and legislative requirements, has been produced.
2 That this documentation, on being reviewed by external auditors, confirms compliance with BS EN ISO 13485
3 When completed, this documentation will show that the OCE system complies with the legislative exemptions after review."]},{"key":"dc:title","label":"Title","values":["Development of UK legislation Guidance for Research Medical and In Vitro Diagnostic Devices"]}]}],"canonical_facts":{"dc:contributor.advisor":["Huang, Zhihong","Li, Chunhui"],"dc:creator":["Carena, Amedeo Patrizio"],"dc:date":["2021"],"dc:date.issued":["2021"],"dc:description.abstract":["Background: Legislation controls the research, design, development and manufacture of medical devices and in vitro diagnostic devices in the United Kingdom (UK) and the European Union (EU). Organisations working in this field can demonstrate their regulatory compliance to this legislation by being accredited to BS EN ISO 13485 – BS EN ISO 13485:2016 ‘Medical devices - Quality management systems - Requirements for regulatory’(1).
The Departments of Medical Physics and Hydatidiform Mole Follow-Up (Scotland) (HMFUS), collectively referred throughout this thesis as M&H, within Ninewells Hospital NHS Tayside are accredited to this standard to allow them to undertake research, design, development and manufacture of medical and in vitro diagnostic devices. This accreditation also enables medical and in vitro diagnostic devices to be European Conformity (CE) marked to the appropriate EU directive or regulation(180).
Aim: The aim of this project is to ensure academics and third parties collaborating with M&H meet the legislative and regulatory requirements for the development of those medical or in vitro diagnostic devices to be placed within a healthcare environment.
Method: A review of the new Medical Device Regulations (MDR)(2), In Vitro Diagnostic Device Regulations (IVDR)(3) and UK Medical Devices Legislation(4), alongside the requirements of the 2016 revision of the BS EN ISO 13485 standard, to ensure the continuing accreditation within M&H. A case study of the research project – ‘the ‘Optical Coherence Elastography’ system, will be undertaken to gain an understanding of the regulatory documentation required.
Results: The development of documentation that must be followed by academics and third parties carrying out research and the devolvement within M&H to ensure their projects meet the requirements of the legislation and BS EN ISO 13485:2016 regulatory requirements. This documentation must also be followed by M&H to ensure their projects meet both the legislative and the regulatory requirements.
Conclusion:
1 That the documentation, required to ensure the work in relation to MDR and IVDR devices meets the regulatory and legislative requirements, has been produced.
2 That this documentation, on being reviewed by external auditors, confirms compliance with BS EN ISO 13485
3 When completed, this documentation will show that the OCE system complies with the legislative exemptions after review."],"dc:identifier":["oai:discovery.dundee.ac.uk:studenttheses/4e31417e-50e1-4c22-9030-18ad357bef5a","https://discovery.dundee.ac.uk/en/studentTheses/4e31417e-50e1-4c22-9030-18ad357bef5a"],"dc:identifier.uri":["https://discovery.dundee.ac.uk/files/55179233/Carena_PhD_Thesis_2021.pdf"],"dc:language":["eng"],"dc:publisher.department":["Biomedical Engineering"],"dc:publisher.institution":["University of Dundee"],"dc:relation.isreferencedby":["https://discovery.dundee.ac.uk/en/studentTheses/4e31417e-50e1-4c22-9030-18ad357bef5a"],"dc:subject":["Medical Devices Regulations","In Vitro diagnostic Devices Regulations","Medical Qaulity Assurance","13485","9001"],"dc:title":["Development of UK legislation Guidance for Research Medical and In Vitro Diagnostic Devices"],"dc:type":["Thesis"],"dc:type.qualificationlevel":["Master's Thesis"],"dc:type.qualificationname":["Master of Science"]},"updated_at":"2026-07-24T02:08:59Z"}