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Letter about new Medical Device Standards Orders

May 2008

The following letter was sent to stakeholders at the end of May 2008.

Dear Stakeholder

Medical Device Standards Order (Standards for Clinical Evidence) 2008; and
Medical Device Standards Order (Standards for Risk Management) 2008

I wish to advise that the Therapeutic Goods Administration (TGA) has revoked and replaced Medical Devices Standards Order (MDSO) No. 1 Standards for Clinical Evidence 2003 and MDSO No. 2 Standards for Risk Management, that were both made on 20 February 2003 and gazetted on 5 March 2003, with the above two 2008 MDSOs. This follows stakeholder comments in early 2008 on the proposal to update the two 2003 MDSOs to reflect the latest international standards.

The new MDSO (Standards for Clinical Evidence) 2008 which replaces MDSO No. 1 Medical Device Standards for Clinical Evidence 2003 introduces the following new standards for clinical evidence:

  • AS ISO 14155-1: 2004 - Clinical investigation of medical devices for human subjects - General requirements;
  • ISO 14155-1: 2003 - Clinical investigation of medical devices for human subjects - General requirements (which is identical to AS ISO 14155-1: 2004)
  • AS ISO 14155-2: 2004 Clinical investigation of medical devices for human subjects - Clinical investigation plans
  • ISO 14155-2: 2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans (which is identical to AS ISO 14155-2: 2004);
  • ISO 5840: 2005 Cardiovascular implants - Cardiac valve prostheses; and
  • ISO 11979-7: 2006 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations.

The new MDSO (Standards for Risk Management) 2008 which replaces MDSO No. 2 Medical Device Standards for Risk Management 2003 introduces the following new standards for risk management:

  • EN ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices; and
  • ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices (which is identical to EN ISO 14971: 2007)

MDSO (Standards for Risk Management) 2008 also makes the condition that the following two standards will no longer apply after 31 March 2010:

  • EN ISO 14971: 2000 Medical Devices - Application of Risk Management to Medical Devices;
  • ISO 14971: 2000 Medical Devices - Application of Risk Management to Medical Devices (which is identical to EN ISO 14971: 2000)

A copy of both 2008 MDSOs are attached for your information.

MDSO (Standards for Risk Management) 2008 commenced on 29 May 2008, the day after it was registered on the Federal Register of Legislative Instruments (FRLI), (FRLI registration number F2008L01699). MDSO (Standards for Clinical Evidence) 2008 also commenced on 29 May 2008, the day after it was registered on FRLI, (FRLI registration number F2008L01700).

A copy of both MDSOs can be found on the TGA website. Electronic or hard copies of the various international standards can be purchased on-line from SAI Global Limited at the following website - http://www.saigloval.com.

Should you have any queries in relation to these documents, please contact Ms Siepie Larkin on Phone (02) 6232 8721 or Email: siepie.larkin@tga.gov.au.

Yours Sincerely

Larry Kelly
A/g Director
Office of Devices, Blood & Tissues

May 2008

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