Medical devices reforms: Mutual Recognition Agreements (MRA)

Project overview

Australia and the United Kingdom (UK) have a Mutual Recognition Agreement (MRA)- external site that replaced the EU-Australian agreement following Brexit.

It provides for the mutual acceptance of conformity assessment for medical devices.

This agreement provides for the UK to recognise Therapeutic Goods Administration (TGA) certificates issued to Australian manufacturers under the UK Medical Device Regulations 2002. See also: UK-Australia Mutual Recognition Agreement.

The part of the agreement that provides for the TGA to recognise certificates issued by a UK Market Conformity Assessment Body (UKMCAB) is not yet operational.

MRAs with the European Community and the European Free Trade Association

The European medical device directives have been replaced by the new Medical Device Regulation (Regulation (EU) 2017/745- external site). As a result, the previous European - Australian MRAs have been superseded and are no longer operational. We worked with all Australian manufacturers that used TGA EU MRA certificates to manage this transition.

More information

•  Department of Industry, Science and Resources