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.

Date of Award	2021
Original language	English
Awarding Institution	University of Dundee
Supervisor	Zhihong Huang (Supervisor) & Chunhui Li (Supervisor)