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EU MDR Transition

Overview and management under the Australian regulatory framework

This guidance is to help Australian medical device suppliers and users transition to the new EU MDR and to understand and meet their obligations under the Australian regulatory framework. 

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Changes

The transition to EU MDR has introduced a range of changes for medical device manufacturers such as:

  • more stringent requirements to demonstrate medical device safety for patients and users including requirements for clinical evidence
  • additional requirements for the manufacturer’s quality management systems 
  • detailed technical document requirements
  • changes to classification rules for medical devices.

Most medical devices may need to transition to the new EU MDR to continue to be approved for supply in Australia.

We recognise that some manufacturers are facing delays in receiving updated certificates from their European notified bodies.

 We also understand that changes brought about by new requirements in Europe will result in changes to products approved for supply in Australia.

To minimise regulatory burden, cost, and impact on supply, we are adopting a risk-based and streamlined approach to allow the transition to EU MDR certification, that does not compromise the safety, quality, or performance of medical devices supplied in Australia.

Manufacturer and sponsor responsibilities

It is your responsibility as the manufacturer or sponsor to ensure you hold valid conformity assessment certification or overseas regulator conformity assessment documents to support your medical devices included in the Australian Register of Therapeutic Goods (ARTG). 

As a result of the EU MDR, some sponsors and manufacturers may need or choose to obtain alternative conformity assessment documentation to support the inclusion of their devices in the ARTG, to continue supply in Australia.

Sponsors also need to ensure compliance with all ARTG conditions applying automatically, and if applicable, any additional conditions imposed. 

We will continue to accept valid certificates issued under the previous European Medical Devices Directive and Active Implantable Medical Devices Directive until their expiry date or 26 May 2024, whichever occurs first. 

We will also recognise these certificates for manufacturers that qualify for the EU MDR transition extension.

Impact of the EU MDR on Australia 

A medical device manufacturer that has transitioned to the EU MDR will have new conformity assessment certification.

However, there may be changes to their devices and associated documentation under the EU MDR, such as the following:

  • change in device classification
  • changes to the scope of indications or intended purpose
  • changes to functional description
  • changes to labelling and instructions for use.

Depending on the type of change and relevance to Australia, sponsors may need to act to ensure the devices they already supply in Australia continue to comply with the Australian regulatory framework.

Transitioning to the EU MDR 

We have developed an Online assessment tool and notification form to assist with the transition.

Sponsors also have the option to use the EU MDR Transition web publication service to provide market notifications to health care providers and consumers for devices going through low-risk changes as part of the EU MDR transition.

Summary

The following table outlines the changes that may result from the transition of devices to the EU MDR, and the associated regulatory actions that sponsors may be required to undertake. 

ChangeRegulatory action
New MDR certification

You can update your manufacturer evidence on file to an MDR certificate by submitting an ME variation application.

Alternatively, if you need to retain the old manufacturer evidence on file (as it may be linked to other entries), you can submit a New ME application, and when it is accepted, submit a DCR to link your entry to the new ME.

Changes to device classification under the Australian regulatory frameworkYou will need to lodge new applications for inclusion for your affected ARTG entries.

Changes to any of the following (for all classifications):

  • intended purpose
  • Global Medical Device Nomenclature (GMDN) code and term
  • linking an existing ARTG inclusion to a new manufacturer evidence identifier (e.g. if the new EU MDR certification was submitted as new manufacturer evidence and given a new identifier)
  • manufacturer details (name or address). Changes to manufacturer details must be limited to the same legal entity and be supported by evidence. If the manufacturer legal entity changes, or products are transferred to a new manufacturer, a new application for inclusion must be lodged for the affected ARTG entries.
You can update your ARTG entries by submitting DCR applications for your affected ARTG entries.

Changes to any of the following (for class III or AIMD):

  • variant specifications
  • total number of devices (if there is an impact on the total number of models because of changes to variant specifications)
  • UPI (Unique Product Identifier)
  • functional description.
You can update your ARTG entries by submitting variation applications for your affected ARTG entries.

Changes to any of the following:

  • indications in 'Instructions For Use'
  • class of persons for which the device is suitable for
  • reduction in scope of intended purpose
  • functional description
  • addition of a warning for a newly identified safety issue or contraindication
  • addition of adverse event information which would change patient management recommendations.

If you meet all 6 of the eligibility criteria for streamlined market notifications, outlined in the Eligibility criteria for streamlined market notifications section below, you can either:

a)    Submit an Online Notification Form to use our EU MDR Transition web publication service to provide market notifications to health care providers and or end users

or

b)    Notify health care providers or end users about changes to their devices and maintain documentation to confirm that the notifications had occurred and be able to produce them to us upon request.  

If you do not meet all 6 of the eligibility criteria for streamlined market notifications, outlined in the Eligibility criteria for streamlined market notifications section below, you will need to submit new recall notifications following our established recalls procedure.

Non-compliant with the Essential PrinciplesYou will need to lodge a Consent to supply application for your affected medical device ARTG entries.

Impact on providers and procurement areas

We are actively managing the impact of the EU MDR transition in Australia to minimise supply disruptions for Australian patients, health services and procurement areas.

See How we are managing medical device supply disruptions resulting from changes in Europe .

Background

Medical device regulation in Europe is undergoing transition to replace the existing Medical Devices Directive and the Active Implantable Medical Devices Directive with the new Medical Devices Regulation (MDR). 

The EU MDR was published in May 2017 and applied from 26 May 2021, with an ongoing transition. 

This transition is having a flow on effect to sponsors who supply medical devices in Australia.

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