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Guidance
for Applications with Medical Devices for gaining regulatory
approvals including R&D, MHRA and REC. |
Introduction
All devices and equipment used in research and development must be managed in accordance with the Trust policy for the Management of Medical Equipment which is available on the Trust's intranet site. In particular:
All medical equipment will be subject of appropriate acceptance tests by the Department of Medical Physics and Engineering, (or the Departments Pathology or Pharmacy for specialist equipment within their areas of responsibility) before clinical use.
The clinical user should test the device for operational safety before it is used on a patient.
Equipment developed as part of a research and development project or modified in any way to provide a clinical service; is subject to the following conditions:
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It must be designed, constructed or modified, developed and tested by, or under the supervision of, appropriately qualified staff (appropriately qualified staff will include a chartered electrical, clinical or mechanical engineer for all electrical, electronic or mechanical devices) within an appropriate quality system (for example, EN46000).
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It must comply with the requirements of the Medical Device Regulations (2002) (see www.mhra.gov.uk) and other appropriate legislative requirements and codes of practice.
Medical Devices Regulations
The Department of Health's Medicines & Healthcare products Regulatory Agency is the Competent Authority for the UK and has the responsibility for implementing the provisions of these Directives in the UK .
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