April 2008
The National Research Ethics Service is today publishing two guidance documents on medical devices research:
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Approval of medical devices research (pdf 276 KB).
This is an updated version of a document originally published in draft for use and comment in December 2006, setting out comprehensive guidance on arrangements for approval of medical devices research in the UK. The main changes relate to the introduction of the Integrated Research Application System (IRAS) in January 2008. It is now possible for researchers to prepare and submit applications to NHS RECs, NHS R&D offices and, where necessary, the MHRA using the single system for data entry in IRAS. Please see https://www.myresearchproject.org.uk for further information and access to IRAS.
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Communications on medical devices research (pdf 60 KB).
This document describes agreed arrangements for communications between NHS RECs and the MHRA in relation to clinical investigations of non-CE marked medical devices subject to the Medical Devices Regulations 2002. Regulatory oversight and ethical review of devices investigations have distinct purposes but they have a shared aim of ensuring the safety and well being of research participants. Communication of relevant information between the two systems will help to achieve this. The MHRA and the NRES, on behalf of NHS RECs, are committed to facilitating such communication wherever possible, subject to compliance with duties of confidentiality. The guidance sets out how this will be achieved.
Both guidance documents have been developed by the Medical Devices Research Collaboration Group. This is a group with representation from the Medical and Healthcare products Regulatory Agency (MHRA) Devices Division, the NHS Research & Development Forum, the Association of British Healthcare Industries (ABHI) and the Institute of Clinical Research (ICR) Medical Devices Sub-Committee, as well as NRES.
