Device - MRA application

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The Mutual Recognition Agreement (MRA) is a treaty between the Governments of Australia and the European Community. It applies to all medical products which are industrially manufactured in Australia and the European Union and to which Good Manufacturing Practise (GMP) requirements apply.

For medical devices,
• the MRA recognises the competence of 18 nominated conformity assessment bodies in the European Union to undertake conformity assessment to the quality, safety and efficacy of medical devices to Australian requirements for entry on the Australian Register of Therapeutic Goods (ARTG).
• Conversely, the European Union recognises the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification ('CE marking') and hence entry on the EU single market.
  

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