Study Group 5 Chair

Susan Ludgate
Clinical Director (Devices) Medicines
and Healthcare Products Regulatory Agency (MHRA)
e-mail: Susanne.Ludgate@mhra.gsi.gov.uk

DR SUSANNE LUDGATE

Dr Susanne Ludgate FRCR, FRACR

Dr Susanne Ludgate qualified in medicine from Edinburgh University, subsequently specialising in Radiation Oncology and was appointed a Consultant at the Western General Hospital, Edinburgh in 1979.

She subsequently took up a Consultant post in Radiation Oncology at Westmead Hospital in Sydney and at the Peter McCallum Hospital in Melbourne, publishing and lecturing widely.

She was appointed Medical Director of the Medical Devices Agency in 1993. She has been responsible for the setting up and management of the clinical investigation system of new medical devices under the provisions of the Medical Devices Regulations. She is a member of the European Commission’s Clinical Evaluation Task Force on Clinical Investigations, a member of the Global Harmonisation Task Force on Clinical Evaluation, and has helped to write both the CEN and ISO Standards relating to clinical investigations of medical devices.

She is a member of the Department of Health’s Advisory Committee on Topic Selection for NICE, a member of the Health Technology Assessment Diagnostic Technology Screening Panel, a member of the NICE Advisory Committee on Interventional Procedures and a member of the NICE CJD Advisory Committee. She has published extensively on the Medical Devices Regulations, the handling of clinical investigations and the reporting and handling of device related adverse events.

As part of the new MHRA structure, Susanne now holds the position of Devices Clinical Director and is a member of the MHRA’s Executive Board.

PS/LD

Updated 12 September 2007

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