Webinar presentation: EU MDR Transition – Overview and management under the Australian regulatory framework

Yes, the webinars are recorded and have been made available on our website.

As part of supplying medical devices to the Australian market, sponsors are responsible for communicating with their customers about changes to their products. The TGA has developed the web publication service as an option to reduce the burden of this responsibility on sponsors and on customers during the MDR Transition. The TGA has also worked with health service procurement groups to raise awareness of the web publication service.

If seeking to update the ME on file from EU MDD to MDSAP, Sponsors can lodge an ME Variation application. This will result in all ARTG entries associated with the EU MDD certificate to now be associated with the MDSAP certificate as the ME on file has been updated. If seeking to retain the MDD certificate for some ARTG entries, and update other ARTG entries to the MDSAP certificate, then a New ME Application can be lodged for the MDSAP certificate, followed by a DCR application to link the ARTG entries to the new MDSAP ME.

The EU MDR transition has no impact sponsor on ARTG entries supported by Manufacturer Evidence based on MDSAP certification.

It is a legislative requirement that active ARTG entries have valid Manufacturer Evidence (ME). Provided the sponsor notifies us within 60 days of the MDD certificate expiry, and there are no safety concerns, the TGA will normally allow 12-months before considering cancellation of ARTG entries that are no longer supported by an MDD certificate or other accepted ME. This will allow the sponsor to continue to supply stock that has been manufactured under the MDD certificate for 12-months. The 12-month limit to exhaust stock that was covered by an expired MDD certificate is similar to the EU MDR Article 120 (4) "sell-off" provision at this time.

Sponsors can lodge an ME Variation application. The ARTG entries associated with the EU MDD certificate will then be associated with the new overseas regulator evidence instead. If seeking to retain the MDD certificate for some ARTG entries, and update other ARTG entries to the new certificate, then a New ME Application can be lodged for the new certificate, followed by a DCR application to link the ARTG entries to the new Manufacturer Evidence.

There are criminal and civil penalty sanctions if a sponsor fails to notify the TGA within 60 days of becoming aware that the MDD certificate is no longer in effect. The notification allows the sponsor to tell us they are waiting for MDR certification and when it is expected.

At all times, while the inclusion of the device in the ARTG has effect, the sponsor must have available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device in the ARTG and ensure compliance with all conditions stated in section 41FN of the Act, and if applicable, any additional product specific conditions imposed when the device is included in the ARTG.

Instead of cancelling ARTG entries that are no longer supported by an MDD certificate and not supported by other accepted ME, the TGA is allowing the ARTG entry to remain active for sponsors to continue to supply stock that has been manufactured under the MDD certificate. Sponsors can prove to customers that they are able to continue to supply due to the ARTG entry being active.

The 12-month limit to exhaust stock that was covered by an expired MDD certificate is in line with the EU MDR approach at this time.

As long as you are supplying products that have been manufactured prior to the MDD certification expiration, there is no need to halt supply whilst you wait for the TGA’s response.

TGA is in communication with the EU regarding a Mutual Recognition Agreement to enable TGA to grant certification per the 2017/745 MDR. However, there are no set timeframes for this to occur.

This would be assessed on a case-by-case basis. It is expected you would notify the TGA if your transition to MDR is taking longer than 12 months.

The fee reduction measures are limited to consent to supply applications where the non-compliance is associated with EP13, and also to device change requests where the change is to update ME identifiers to MDR. There are no fee reductions for new applications for inclusion or annual charges.

For financial year 2021/22, the median timeframe for new applications for conformity assessment was 139 business days not including days where a request for information was outstanding. The legislated timeframe for decisions on conformity assessment applications requiring review of device design (class III) is 255 business days not including days where a request for information is outstanding.

If the manufacturer chooses to transition from the EU MDD to the MDSAP, the sponsor can update the ME to reflect that. If there is a gap between the expiry of the EU MDD certificate and the issuance of the MDSAP certificate, the sponsor must notify the TGA within 60 days of the EU MDD certification expiry.

Under our framework, we require evidence of conformity as outlined in the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018.

If the new MDR certificate covers the scope of the products in the ARTG entry, then there is no time limit associated with the supply of MDD stock.

Under our framework, we require evidence of conformity as outlined in the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018. 

Refer to the requirements for your device based on the risk classification.

The device classification in Australia is generally aligned with the EU MDR, though there are some differences. Therefore, the regulatory pathway and classification will depend on the product’s intended use, and what is defined in our legislation and classification rules.

If the transition to MDR requires the addition of a new warning to the labelling, the TGA would consider the previous stock manufactured without this warning a breach of Essential Principle 13, Item 5 which states “Any warnings, restrictions, or precautions that should be taken, in relation to use of the device, must be provided with the device”. 

A Consent to supply approval is required to supply any devices that are in breach of the Essential Principles.

As of 26 May 2021, MDD certificates can no longer be issued, modified, amended, or supplemented by a Notified Body.

Under Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), devices which have a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.

Conditions referred to in the previous paragraph require that no significant changes in design or intended purpose of a device be performed after the date of application of the MDR. Any administrative changes should be verified by the notified body during this transition period to ensure that the MDD certificate remains valid.

Administrative changes of organisations are considered in principle as a non-significant change. This includes changes of the manufacturer’s name, address or legal form (legal entity remains) or changes of the authorised representative.

The TGA would expect to see evidence that the notified body has assessed the new manufacturer details under Article 120(3) of the MDR, and that certificate remains valid. Evidence of verification under Article 120(3) may be provided in the certificate itself, or as a letter from the Notified Body.

Further guidance on MDR Article 120(3) has been published by the European Union to support manufacturers and sponsors with the transition.

At all times, while the inclusion of the device in the ARTG has effect, the sponsor must have available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device in the ARTG and ensure compliance with all conditions stated in section 41FN of the Act, and if applicable, any additional product specific conditions imposed when the device is included in the ARTG.

If the ME has changed (e.g. from EU MDD to MDSAP), the sponsor can choose to update the relevant ME to reflect the MDSAP certificate, or simply hold the evidence and be able to provide it upon request by the TGA. There is no legislative requirement to keep the ME up to date, though we do encourage all sponsors to keep their ARTG entries up to date.

No, the proposed DCR fee reduction is limited to the delink and relink of ME identifiers only.

It would be on a case-by-case basis. If the number of devices supplied is vastly different to what was originally notified, then yes, the TGA would expect an update via email.

That is a decision for the healthcare provider to make.

An example of a market notification direct from the sponsor to their customers could take the form of a letter, similar to other commercial correspondence, but in this case, advises of the non-safety related changes to their products as part of the MDR Transition process.

Notification of conformity certification expiry should be done using the Lapses in medical device conformity assessment certification notification form. If you have more than 20 ARTG entries which are expiring, you can write to dvs@health.gov.au to discuss an alternative

Labelling requirements are outlined in Essential Principle 13.

Consent to supply is required for any product that has a known breach of the Essential Principles. 

If your product is compliant with the Essential Principles, you do not need consent to supply.

Sponsors can update their manufacturer evidence on file with the new MDR certificate by lodging an ME Variation application. This will result in all ARTG entries associated with the EU MDD certificate to now be associated with the EU MDR certificate as the ME on file has been updated. If seeking to retain the MDD certificate for some ARTG entries, and update other ARTG entries to the EU MDR certificate, then a New ME Application can be lodged for the EU MDR certificate, followed by a DCR application to link the ARTG entries to the new EU MDR ME. The applications are made through your TGA eBS account.

Sponsors are encouraged to keep their ARTG entry up to date. If the MDR indications are broader, sponsors can submit a DCR application to update the intended purpose for their devices, you would be expected to provide supporting evidence for the broader indications.

This is a sponsor/business decision. You as a sponsor can apply for an ARTG inclusion now using MDD certification if you wish. Note that class III applications supported by MDD certification will be subjected to a mandatory application audit. Also, should the application be approved, the device can only be manufactured whilst the certificate is valid. You will need to notify the TGA within 60 days of the certification expiry and are expected to cease supply within 12 months of MDD certification expiry if there are no valid certification thereafter.

Streamlined market notifications is for low-risk changes. Sponsors must meet all 6 criteria to qualify. The 6 criteria can be found at Recalls and market notifications.

Consent to supply is required to continue to supply a device that has a known breach of the Essential Principles. 

If your transition to MDR is taking longer than 12 months, it is expected you would notify the TGA, and the TGA will assess whether or not to take action on the ARTG. This will be assessed on a case-by-case basis.

The sponsor or manufacturer is best placed to determine the appropriate conformity assessment pathway for their devices. Regardless of conformity assessment pathway, sponsors must notify the TGA within 60 days of their conformity assessment certification expiry and are expected to cease supply within 12 months of MDD certification expiry if there are no valid certification thereafter.

As part of supplying medical devices to the Australian market, it is the sponsor’s responsibility to ensure all information about their products is accurate, up to date and communicated appropriately to their customer base. The TGA has developed the web publication service, as an option, to assist sponsors in this regard as part of the EU MDR Transition process.

Yes, there are criminal and civil penalty sanctions if a sponsor fails to notify the TGA within 60 days of becoming aware that a conformity assessment document (other than a conformity assessment certificate issued by the TGA) has been restricted, suspended, revoked or is no longer in effect. However, if you cancel the ARTG entry on the day of expiration, no notification is necessary.

For class 3 IVD medical devices, the TGA will continue to accept valid EU IVDD certificates until their expiry date or 26 May 2026, whichever date occurs first. Following this, the sponsor will need to transition the ARTG entries supported by IVDD to either IVDR or any other acceptable comparable overseas certification. Refer to Use of comparable overseas manufacturer evidence for information on acceptable manufacturer evidence for Class 3 IVDs.

For manufacturer evidence that is associated with multiple ARTG entries, which are transitioning at different times, Sponsors can choose to update their Manufacturer Evidence when all related ARTG entries have transitioned to the EU MDR, or to update the Manufacturer Evidence as and when certain ARTG entry(s) transition to the EU MDR. This is a decision for the sponsor based on how they would like to manage their ARTG entries.

Yes, class I non-sterile non-measuring devices do not require conformity assessment certification before they can be included in the Australian Register of Therapeutic Goods (ARTG). 

They are included in the ARTG on the manufacturer's declaration that the devices comply with the relevant Essential Principles for safety and performance.

As long as you are supplying products that have been manufactured prior to the MDD certification expiration, there is no need to halt supply whilst you wait for the TGA’s response.

Notification form: Lapses in medical device conformity assessment certification

Yes, if the risk classification changes under the Australian regulatory framework, then a new application of inclusion is required as the device is considered a new kind of device and the sponsor should cancel their old ARTG entry.

If you have a device change request (DCR) application underway, email EUMDRTransition@health.gov.au to advise of your specific situation and the team will work with you to minimise supply disruptions.

The TGA cannot grant consent to supply devices that have not been manufactured using valid conformity assessment certification. Devices that are manufactured without valid ME certification cannot be supplied in Australia.

Use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s) - Notification form: Lapses in medical device conformity assessment certification

Sponsors holding TGA CAC are not affected by the EU MDR transition.

If you have more than 20 ARTG entries which are expiring, you can write to dvs@health.gov.au to discuss an alternative method of notifying

Yes. For manufacturer evidence that is associated with multiple ARTG entries, which are transitioning at different times, Sponsors can choose to update their Manufacturer Evidence when all related ARTG entries have transitioned to the EU MDR, or to update the Manufacturer Evidence as and when certain ARTG entry(s) transition to the EU MDR. This is a decision for the sponsor based on how they would like to manage their ARTG entries.

Sponsors must notify the TGA within 60 days of their conformity assessment certification expiry and are expected to cease supply within 12 months of MDD certification expiry if there are no valid certification thereafter.

The Therapeutic Goods Act 1989 outlines your responsibility as a Sponsor. It is expected you would act accordingly while the inclusion of the device in the ARTG has effect.

No, consent to supply is specific to non-compliances against the Essential Principles.

At all times, while the inclusion of the device in the ARTG has effect, the sponsor must have available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device in the ARTG and ensure compliance with all conditions stated in section 41FN of the Act, and if applicable, any additional product specific conditions imposed when the device is included in the ARTG.

If the ME has changed (e.g. from EU MDD to EU MDR), the sponsor can choose to update the relevant ME to reflect the EU MDR certificate, or simply hold the evidence and be able to provide it upon request by the TGA. There is no legislative requirement to keep the ME up to date, though we do encourage all sponsors to keep their ARTG entries up to date.

Sponsors must notify the TGA within 60 days of their conformity assessment certification expiry - Notification form: Lapses in medical device conformity assessment certification

No. Depending on what the changes are, Sponsors will need to use the appropriate form for the change. If sponsors would like to update their GMDN codes to a more relevant one which does not change the kind of device, then a DCR application would be required. Similarly, for intended purpose changes, sponsors would need to lodge a DCR application. To update manufacturer evidence on file, sponsors will need to lodge an ME variation application. For changes to device classification, that would require a new application for inclusion.

The changes are already happening and will continue as notified bodies in Europe assesses and issues MDR certifications to manufacturers. Approval processes remain the same for existing and new applications. Where possible we will be streamlining our processes to minimise approval delays.

No, these changes can be communicated via the market notification process if they are part of an MDR Transition, but sponsors should ensure that all six eligibility criteria are satisfied first.

Recalls and market notifications

The timeframe for approval is dependent on the information that is provided by the Sponsor with the application. There is a 24-hour delay from the application being paid for and the consent to supply team being able to see the application has been paid. If information provided is sufficient for the TGA to make a decision, a decision is usually provided within 5 working days of the application being paid.

At all times, while the inclusion of the device in the ARTG has effect, the sponsor must have available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device in the ARTG and ensure compliance with all conditions stated in section 41FN of the Act, and if applicable, any additional product specific conditions imposed when the device is included in the ARTG.

If the ME has changed (e.g. from EU MDD to EU MDR), the sponsor can choose to update the relevant ME to reflect the EU MDR certificate, or simply hold the evidence and be able to provide it upon request by the TGA. There is no legislative requirement to keep the ME up to date, though we do encourage all sponsors to keep their ARTG entries up to date.

Products with MDSAP certification are not affected by the EU MDR Transition. Class I non-sterile non-measuring devices do not require conformity assessment certification before they can be included in the Australian Register of Therapeutic Goods (ARTG). 

They are included in the ARTG on the manufacturer's declaration that the devices comply with the relevant Essential Principles for safety and performance.

All devices must comply with all Essential Principles. 

Devices for supply in Australia must comply with Essential Principle 13. 

MDR labelling requirements which have no bearing on Essential Principle 13 are not relevant under our framework.

Whether a product is regulated as a medical device in Australia will depend on whether it meets the definition of a medical device under our legislation. At times, there are products which are regulated as medical devices in Europe, but are medicines in Australia, or products that are regulated at a lower classification in Europe but is a higher classification in Australia. Therefore, the regulatory pathway and classification will depend on the product’s intended use, and what is defined in our legislation and classification rules.

At this stage, the UK is not recognised under the TGA's comparable overseas regulator arrangements for medical devices, with the UK currently considering longer term options for ongoing regulation of medical devices. 

This is not expected to cause any practical issues given the two UK conformity assessment bodies are also operating as notified bodies in the EU and so in practice are likely issuing both CE and UKCA certificates for products. If manufacturers or sponsors do experience any issues contact the TGA. 

This will be reviewed as details of UK plans for ongoing regulatory arrangements are released.

If you hold a valid MDD conformity assessment certification and are not seeking to transition to the EU MDR and are not seeking to obtain any other conformity assessment certification such as the US FDA, then you can continue to manufacture your devices whilst your certification is valid. Sponsors are required to notify us within 60 days of the certification lapsing or expiring, and can supply the devices that were manufactured under a valid certificate for a 12 month period following certification expiry, but are expected to cease supply thereafter.

Clinical evidence is usually reviewed for class III applications subjected to mandatory audits during the inclusion process for devices supported by MDD certification. Given that the MDD certification has expired and the new MDR certification no longer supports the use of the device on children, the TGA may request the clinical evidence to demonstrate the device remains appropriate for the intended use.

The TGA is monitoring the situation in Europe and will align our approach with the EU where possible, to minimise supply disruptions.

Sponsors are expected to obtain conformity assessment within 12 months of their MDD certification expiry. If sponsors do not hold valid conformity assessment certification after the expiry of their EU MDD certification, they are expected to cease supply within 12 months following their EU MDD certification expiry.

Sponsors are expected to cease supply within 12 months following their EU MDD certification expiry. Therefore, if a sponsor holds a valid MDD certificate which expires on 26 May 2024, they are expected to cease supply of their MDD stock by 26 May 2025.

You will need to check with your EU notified body and ask for the checklist for Essential Requirements under MDD or GSPRs under MDR.

Yes, it is the TGA’s intention to align AU EPs with GSPRs under EU MDR. We do not have timeframes on this yet.

For the supply of medical devices in Australia, the TGA only requires that the safety and performance characteristics of the medical devices meet the Essential Principles (EPs) set in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002, and that compliance with EPs are maintained throughout the device’s lifecycle.

GSPRs are requirements under the EU Medical Device Regulation (MDR) 2017/745.

The TGA intends to align AU EPs with GSPRs under EU MDR. However, we do not have timeframes on this yet.

It is a legislative requirement for active ARTG entries to have appropriate ME to support the entry.

We are aware of some classification differences between the EU and Australia and are working with the EC on resolving them where possible. 

Under our framework, we accept evidence of conformity as outlined in the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018. 

Refer to this determination for other sources of acceptable evidence for your device based on the risk classification in Australia.