MDEC meeting 2007/4, 7 December 2007

Medical Device Evaluation Committee

Meeting report

The 2007/4 (16th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 7 December 2007. The main points of discussion included:

• an application by Stryker Australia Pty Ltd for the provision of a conformity assessment certificate for the DuraMatrix collagen dura substitute membrane for use as a dural substitute for the repair of dura mater.
• consideration of the activity reports from the MDEC Subcommittees and Expert Advisory Groups.

The 2008/1 MDEC meeting is proposed for 28 March 2008.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions of the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.

Bioengineering and Biomaterials Subcommittee (BBC) Report - Human Health Toxicity Risk Assessment of di (2-ethylhexyl) phthalate (DEHP) in Medical Devices

RES NO. 2007/24

MDEC accepted the report: Human Health Toxicity Risk Assessment of DEHP in Medical Devices. This report was commissioned by TGA at MDEC's request, and prepared by the National Chemicals Notification and Assessment Scheme (NICNAS) to investigate the risks to human health of di (2-ethylhexyl) phthalate (DEHP).

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