MDEC meeting 2005/4, 9 December 2005

Medical Device Evaluation Committee

Meeting report

The 2005/4 (9th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 9 December 2005. The main points of discussion included -

• The application for a variation to the registration by Edwards LifeSciences Pty Ltd for the Carpentier Edwards Perimount Bovine Pericardial Heart Valves for the replacement of malfunctioning native or prosthetic heart valves to be used in humans.
• The application by Inamed Australia Pty Ltd for the provision of a conformity assessment certificate for Zyderm 1 Collagen Implant, Zyderm 2 Collagen Implant and Zyplast Collagen Implant for the correction of contour deformities of the dermis in non-weight bearing areas.
• The application by Inamed Australia Pty Ltd for the registration of Cosmoderm 1 Collagen Implant, Cosmoderm 2 Collagen Implant and Cosmoplast Collagen Implant for the correction of contour deformities of the dermis in non-weight bearing areas.
• The European proposal for the reclassification of joint replacement prostheses.
• Update on the tender for a consultancy to assess the cost benefits of a national medical device tracking system.
• Process for the distribution of ratified MDEC minutes to sponsors.

The 2006/1 MDEC meeting is proposed for 24 March 2006.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions made by 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.

Minutes of the previous meeting

RES NO. 2005/27

The minutes of the 2005/3 (8th) meeting of the Medical Device Evaluation Committee (MDEC) are accepted and ratified as a true record.

Reclassification of hip, knee and shoulder joint replacements

RES NO. 2005/32

MDEC notes the European Commission's Directive for the reclassification of joint replacement prostheses and TGA's consideration of the merits of the proposed European Directive on the reclassification of hip, shoulder and knee implants.

MDEC recommends that Australia continues to classify joint replacement prostheses as Class IIb for the present time, but recommended that a close alignment with the Global Harmonisation Task Force (GHTF) is maintained.

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Standard Operating Procedure for MDEC ratified minutes to sponsors

RES NO. 2005/33

MDEC endorsed the introduction of a process for the distribution of edited extracts of ratified minutes to sponsors, based on:

1. Minutes are 'edited' and provided to sponsors at the earliest possible time after the meeting where the Minutes are ratified;
2. For the purposes of this Resolution, 'edited' means:
   1. Deletion of:
      1. Trade secrets and/or commercial-in-confidence information;
      2. Reference to whether agreement was unanimous or not;
      3. Reference that will personally identify Members; and
      4. Any other information for which public disclosure is inappropriate.
3. Edited text is to be replaced with X's to indicate where there has been a deletion.

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