Federal Register of Legislation - Australian Government

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Orders/Other as made
This Order revokes Medical Device Strandards Order No. 2 - Medical Device Standards for Risk Management and introduces new and updated standards (or parts of these standards) published by standards organisations that are relevant to risk analysis and risk management methods for medical devices in order to demonstrate compliance with the essential principles.
Administered by: Health
Registered 28 May 2008
Tabling HistoryDate
Tabled HR29-May-2008
Tabled Senate16-Jun-2008
Date of repeal 01 Oct 2018
Repealed by Sunsetting

COMMONWEALTH OF AUSTRALIA

 

Therapeutic Goods Act 1989

 

MEDICAL DEVICE STANDARDS ORDER (STANDARDS FOR RISK MANAGEMENT) 2008

 

 

 

I, LARRY KELLY, delegate of the Minister for Health and Ageing for the purposes of section 41CB of the Therapeutic Goods Act 1989 and acting under that section, HEREBY:

 

(1)          REVOKE “Medical Device Standards Order No 2 – Medical Device Standards for Risk Management” made on 20 February 2003, AND

 

(2)          DETERMINE

 

(a)           that the matters specified in the relevant standards or parts of those standards published by the standards organisations that are specified in column 2 of an item in the Schedule constitute a medical device standard for all kinds of medical devices, subject to the conditions (if any) set out in column 3 of that item of the Schedule, and

 

(b)          that medical devices of those kinds that comply with the standard specified in column 2 are to be treated as complying with those parts of the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002 that are specified in column 4 of the relevant item of the Schedule.

 

This Order commences on the day after it is registered in the Federal Register of Legislative Instruments. 

 

Dated this          19th        day of          May         2008

 

 

 

Signed

 

Larry Kelly

Delegate of the Minister for Health and Ageing


 

Schedule

 

1

Item No.

2

Medical Device Standard

3

Conditions

4

Essential Principle

1

EN ISO 14971:2000  Medical Devices – Application of Risk Management to Medical Devices

Clauses 1 to 9 inclusive

 

OR

 

ISO  14971:2000  Medical Devices – Application of Risk Management to Medical Devices

Clauses 1 to 9 inclusive

 

(Note: EN ISO 14971:2000 is identical to ISO 14971:2000)

 

OR

 

EN ISO 14971:2007  Medical Devices – Application of Risk Management to Medical Devices

Clauses 1 to 9 inclusive

 

OR

 

ISO 14971:2007  Medical Devices – Application of Risk Management to Medical Devices

Clauses 1 to 9 inclusive

 

(Note: EN ISO 14971:2007 is identical to ISO 14971:2007)

 

 

To be used as a method to identify the risk associated with the use of the device, but not to be used as a specific means to implement the reduction of risks.

 

 

EN ISO 14971:2000 and ISO 14971:2000 will not constitute a medical device standard for essential principles 1(b) and 2(2) after 31 March 2010.

Schedule 1, paragraph  

1(b) and subclause

2(2)