MEDDESKTOP: Brexit Impact on Medicines In Australia

Brexit - Implications for therapeutic goods in Australia

Medical devices | Medicines

Medical devices
In this section: Brexit 'no deal' | Brexit 'deal' or exit extension | Mutual Recognition Agreement (MRA) | Updating Manufacturer Evidence | Further information

Brexit 'no deal'
In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia.

The Medicines & Healthcare products Regulatory Agency (MHRA) is the UK regulator for medical devices. They have released details of contingency legislation on their website, to ensure continued regulatory oversight and uninterrupted supply of medical devices in the event of a 'no deal' scenario.

If there is a 'no deal' Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG:

Medical devices currently included in ARTG may continue to be imported and/or supplied in Australia with the current certification issued by UK notified bodies, which are subject to continuing MHRA oversight.
Two instruments will be amended to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies:
The Therapeutic Goods (Overseas Regulators) Determination 2018 will be amended to include recognition of notified bodies granted ongoing legal status by the MHRA.
The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG.
Brexit 'deal' or exit extension
Under the proposed Brexit 'deal', UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be no immediate impact on manufacturers certified by these notified bodies. Sponsors of these devices can continue providing these certificates as conformity assessment documents for their medical devices in Australia. Similarly, if the timeframe for the exit of the UK from the EU is extended, current arrangements will continue until an exit occurs.

Mutual Recognition Agreement (MRA)
Separate arrangements under the Mutual Recognition Agreement (MRA) with the EU also provide for recognition of certification issued under that agreement to be recognised in Australia and Europe, and this supports a small number of medical device approvals in Australia, and provides for some Australian medical devices to be supplied in Europe.

The MRA treaty is managed by the Department of Industry, Innovation and Science, who have issued the following statement:

Preparing for Brexit
Updating Manufacturer Evidence
Some notified bodies have arranged or are arranging to transfer EU certificates from UK notified bodies to EU notified bodies (for example, BSI UK to the recently accredited BSI Netherlands).

In such cases where manufacturers now have EU certificates issued by a notified body accredited in one of the EU member states, sponsors may apply to the TGA requesting change of the current certificate.

A standard process for variation of the Manufacturer Evidence (submitting a Manufacturer Evidence application to the TGA) will apply. If replacement of the certificates result in the need to correct information entered on the ARTG, a Device Change Request will also be required.

IMPORTANT

Sponsors must ensure that, at all times while they supply a medical device in Australia, the manufacturer of their medical device holds a valid conformity assessment document that demonstrates that the conformity assessment procedures or requirements comparable to those procedures have been applied to the kind of medical device.