Medical devices reforms: Mutual Recognition Agreements (MRA)

Project overview

Australia and the European Community have a Mutual Recognition Agreement (MRA), which is detailed on the Department of Industry, Science and Resources website. This provides for the mutual acceptance of conformity assessment for medical devices.

This agreement provides for recognition of:

• Therapeutic Goods Administration (TGA) conformity assessment certification issued under
  • the European medical device (93/42/EEC) and
  • active implantable medical device (AIMD) (90/385/EEC) directives
• conformity assessment certification issued by an appropriately designated European notified body under the Therapeutic Goods Act 1989 (and the related regulatory framework).

The European medical device and active implantable medical device directives are being replaced. The new Medical Device Regulation (Regulation (EU) 2017/745) replaces it.

As the existing MRA does not reflect these new arrangements, we are negotiating with the European Commission on possible updates to the MRA. We are not able to issue conformity assessment certification against the new European Medical Device Regulation until updates are in place. We have worked with all Australian manufacturers using MRA certification issued by us, to manage this transition.

Appropriately designated European notified bodies are still able to issue conformity assessment certification under the Therapeutic Goods Act 1989.

There is also a parallel MRA in place between Australia and the European Free Trade Association (Republic of Iceland, Principality of Liechtenstein and the Kingdom of Norway), which will also need to be updated in parallel with the MRA with the European Community.

Australia and the United Kingdom (UK) have signed an MRA covering Conformity Assessment, Certificates and Markings, as detailed on the Department of Industry, Science and Resources website. This MRA also includes for recognition of conformity assessment certification of medical devices.

Guidance for industry

We are unable to issue MRA certification or take on any new MRA clients unless or until the MRA is amended to reflect the new regulatory framework.

Our existing MRA clients have been contacted to manage their MRA certification issued by the TGA through these changes.

For more information on MRAs, see the Department of Industry, Science and Resources website.