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Regulatory Focus™ > News Articles > High Risk Devices to be Excluded From EU Mutual Recognition Agreement

High Risk Devices to be Excluded From EU Mutual Recognition Agreement

Posted 03 December 2012 | By Alexander Gaffney, RAC

High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition Agreement (MRA) concluded between Australia and the EU.

All Class III-high risk-medical devices are excluded from the MRA until the appropriate confidence building activities have been undertaken between the two parties. Also excluded from the amended MRA are certain medical devices containing medicines or materials of biological origin. 

Conformity assessment certificates under the MRA obtained prior to 1 January 2013 will remain valid until expiry or 1 January 2018, whichever is earlier. Australia's Therapeutic Goods Administration (TGA) is encouraging sponsors to contact their manufacturers to confirm that the manufacturer will continue to hold appropriate certification once the amended MRA comes into force. 

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