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Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013

30 November 2012

The Council of the European Union and the Australian Parliament have recently completed all the domestic procedures that are necessary to bring into force a number of amendments to the EU-Australia MRA (Mutual Recognition Agreements) on conformity assessment. This Amended MRA will enter into force on 1 January 2013.

EU-Commission and Australian Therapeutic Goods Administration representatives recently held a preliminary Joint Sectoral Group for Medical Devices meeting in preparation for the introduction of the Amended MRA. This preliminary meeting was held to ensure that both Parties share a common understanding of the key principles of the MRA and to develop a transition plan for the smooth introduction of the Amended MRA.

The outcomes of this meeting will provide device manufacturers and designated conformity assessment bodies with more certainty around the transition arrangements and the relevance of the MRA amendments to their operations.

The majority of the amendments to the MRA are administrative in nature and seek to simplify the management of the MRA. However, the amendments also include some operational changes and will exclude a number of high risk medical devices from the MRA. The majority of these devices will only be excluded until confidence building activities are carried out by both Parties.

In order to ensure that device manufacturers and certification bodies have time to incorporate these MRA changes into their organisational plans, preliminary transition arrangements have been agreed to by the European Union and Australia as follows:

1. Conformity assessment certificates issued under the current MRA for medical devices - that will become excluded from the scope of the MRA by the Amending Agreement - will continue to be valid after the Amending Agreement comes into force until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.
2. Conformity Assessment Bodies that are designated under the current MRA to issue certificates for medical devices - that will become excluded from the scope of the MRA by the Amending Agreement - will be considered to be designated under the Amending Agreement for the purpose of maintaining such certificates until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.
3. Any new conformity assessment certificates issued under the MRA once the Amending Agreement comes into effect must be issued according to the provisions of the new Amended Agreement.

Further work on transition arrangements by the EU-Commission and the Australian Therapeutic Goods Administration will continue once the treaty comes into force. It is proposed that the next meeting of the MRA Joint Sectoral Group for Medical Devices will be held in March of 2013.

Background

Australia has a number of bilateral Mutual Recognition Agreements (MRAs) in place, one of which is the MRA with the European Union in relation to conformity assessment.

The underlying principle of this MRA is that both the European Union and Australia recognise and accept the technical competence of each other's conformity assessment bodies (CABs) to certify products for compliance with the regulatory requirements of the other Party, largely eliminating the need for duplicative testing or re-certification when the goods are traded.

This MRA came into force in 1999 and was the first fully operational MRA of its type in the world. It covers a number of industry sectors in the form of Sectoral Annexes to the Agreement. One of these Sectoral Annexes covers conformity assessment for medical devices.

Negotiations to amend the current EU-Australia MRA were commenced in 2005. The ratification process has been completed by the European Union and Australia, and the Amended MRA will come into force 1 January 2013.

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Details of Amendments

The full text of the Amending Agreement can be accessed at Australian Treaty Series.

The Amending Agreement aims to simplify the MRA's administrative arrangements. It introduces greater flexibility into the MRA by according less-than-treaty status to the Sectoral Annexes. Consequently, the MRA Joint Committee will be able to amend the Sectoral Annexes in response to regulatory and industry developments without needing to go through a full treaty process.

The Amending Agreement also includes a number of changes to the operation of the medical devices Sectoral Annex.

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Information for Australian manufacturers and sponsors of medical devices

While the majority of changes to the Agreement relate to simplifying the administration of the MRA, there are a number of amendments which may change the way in which the MRA applies to some Australian medical device manufacturers and sponsors. These changes include, but are not limited to, the following:

• A 'rule of origin' clause (which stipulates that only those products manufactured in the European Union or Australia are covered by the MRA) has been removed from the overarching MRA and replaced with a more specific clause in the medical devices Sectoral Annex. Activities such as repairing, reconditioning, refurbishment, labelling, packaging, quality control inspections alone, or sterilisation alone, will be specifically excluded from the definition of 'manufacture'.
• Radioactive medical devices of lower risk classes will be included in the MRA.
• The Amending Agreement expands the range of high risk medical devices (including all Class III devices) that will no longer be able to be assessed under the MRA, until confidence building activities have been undertaken by Australia and the European Union.
• The range of excluded barrier contraceptives will also be expanded such that condoms will be excluded from the agreement, until confidence building activities have been undertaken by Australia and the European Union
• The amendments clarify and expand the scope of medical devices containing medicines or materials of biological origin that will be excluded from the MRA.

A number of Australian medical device manufacturers currently hold conformity assessment certification issued by the TGA under the MRA. Only a very small number of manufacturers will be affected by the introduction of the Amended MRA. The TGA is contacting Australian manufacturers who hold certification issued by the TGA under the MRA to provide information on the changes that will be introduced by the Amending Agreement.

A number of medical device ARTG entries are currently supported by conformity assessment certification issued by European Union conformity assessment bodies that are designated under the MRA. As long as the conformity assessment certificate was issued under the MRA prior to 1 January 2013, the certificate will remain valid until its expiry date (or until 1 January 2018, whichever is earlier). The TGA encourages sponsors of such ARTG entries to contact their manufacturers to confirm that the manufacturer will continue to hold appropriate certification once the Amended MRA comes into force. The TGA is contacting sponsors of ARTG entries that are supported by certification issued under the MRA to provide further information on the transition.

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Further questions

For further information regarding the introduction of the Amending Agreement to the MRA please contact the TGA Office of Devices Authorisation.