Medical Device Evaluation Committee (MDEC)

The Medical Device Evaluation Committee (MDEC) is established under Regulation 35 of the Therapeutic Goods Regulations 1990. With the commencement of Australia's new regulatory framework for medical devices on 4 October 2002, MDEC replaces the previous statutory expert committee, the Therapeutic Device Evaluation Committee (TDEC).

The Therapeutic Device Evaluation Committee had a long history in medical devices regulation dating back to 1987.

Role of MDEC

MDEC members are appointed by the Minister for Health and Ageing to provide independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on the safety, quality and performance of medical devices supplied in Australia including issues relating to premarket conformity assessment and post market monitoring.

Membership

The Committee is made up of 12 core members and up to 20 associate members. Together members have expertise in a broad range of disciplines including general medicine practice, gastroenterology, cardiology, anaesthesia, orthopaedics, plastic & reconstructive surgery, neurosurgery, gynaecology/obstetrics, ophthalmology, vascular & transplant surgery, restorative dentistry, biomedical engineering, in vitro diagnostic devices, medical device manufacture and consumer issues.

The Therapeutic Goods Regulations prescribe that the membership of the Committee consists of at least 8, and not more than 12, core members and at least 8, and not more than 20, associate members.

Of the core members, at least:

• 3 persons, each of whom is a medical practitioner eminent in the medical profession and at least 2 of whom are specialists in clinical medicine; and
• 1 person with expertise in consumer issues; and
• 1 person with expertise in industry issues; and
• 1 person who is a biomedical engineer, or who holds a university degree in biomedical engineering; and
• 1 person with expertise in biomaterials, or who holds a university degree in biomaterial science; and

The associate members must include:

• at least 1 person who is a medical practitioner eminent in the medical profession; and
• at least 1 person who is a biomedical engineer, or who holds a university degree in biomedical engineering; and
• at least 1 person with expertise in biomaterials, or who holds a university degree in biomaterial science.

All associate members have specialist qualifications and experience in disciplines complementary to that of the core membership. Associate members are invited by the Chair to attend meetings according to the agenda of each meeting.

MDEC disclosure of interest guidelines <http://www.tga.gov.au/docs/html/mdec/mdec_dig.htm>.

MDEC membership

Note: Decisions on the MDEC are made on a collegiate basis. All correspondence to the committee must be made via the MDEC Secretariat.

Member	Speciality/Expertise
Chairman
Professor Paul O'Brien	Gastrointestinal Surgery
Core Members
Associate Professor Bruce Davis	Cardiothoracic Surgery
Mr Peter Field	Vascular Surgery
Associate Professor Frank Fisher	Consumer Issues, Electrical Engineering
Associate Professor Loraine Holley	Biomedical Engineer, Biophysics
Professor Guy Maddern	Hepatobiliary Surgery
Professor Guy Ludbrook	Anaesthesia
Mr Norman Olbourne	Plastic & Reconstructive Surgery
Dr Laura Poole-Warren	Biomaterials
Dr Gregory James Roger	Industry Issues/Medicine, Biomedical Engineering
Dr Stuart Thomas	Cardiology
Associate Members
Professor Leslie Burnett	In vitro diagnostic devices, Genetics, Pathology
Associate Professor Elizabeth Dax	Serology, Immunology, Microbiology, Virology & In vitro diagnostic devices
Mr Peter Devane	Orthopaedic Surgery
Professor Andrew Downing	Biomedical Engineering
Dr Margaret Evans	Biomaterials
Professor Stephen Graves	Orthopaedic Surgery
Professor Gabor Kovacs	Obstetrics/Gynaecology
Dr Harry Mond	Cardiology
A/Professor Bob Salamonsen	Intensive Care/Anaesthesia
Professor Klaus Schlindhelm	Biomedical Engineering
Dr Michael Steiner	Ophthalmology
Professor Martin J Tyas	Restorative Dentistry
Professor Geoffrey White	Vascular & Transplant Surgery

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MDEC meeting dates

Proposed 2008 MDEC meeting dates

Meeting No.	Cut-off date*	Meeting Date
2008/1 (17)	18 February	28 March
2008/2 (18)	12 May	13 June#
2008/3 (19)	11 August	5 September
2008/4 (20)	3 November	5 December#
Note: These proposed dates are to be confirmed and may be subject to change.
*Cut-off dates are for administrative purposes only
#Meetings proposed to be held in Melbourne. Other meetings to be held in Canberra.

MDEC Secretariat

Secretariat services are provided by the Office of Devices, Blood & Tissues. The contact details for the Secretariat are:

Postal address

The Secretary
Medical Device Evaluation Committee
Office of Devices, Blood & Tissues
Therapeutic Goods Administration
PO Box 100 (MDP 122)
WODEN ACT 2606

Delivery address

Therapeutic Goods Administration
136 Narrabundah Lane
SYMONSTON ACT 2609

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