Presented by: Xin-Lin Goh, Merryn Steer and Craig Davies, Therapeutic Goods Administration
Presented at: Online
Presentation date: Tuesday, 13 December 2022
Presentation summary: This is the last in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR, with a focus on consent to supply and market notifications, and what the Therapeutic Goods Administration (TGA) is doing to streamline the transition process.
Questions and answers
The following are questions that were asked by webinar attendees, and the TGA’s responses. We will update this page with the remaining questions and responses as we work our way through them.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
We will be closely monitoring the situation in the EU and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden.
In the EU, legislative process to enact the proposed EU MDR extensions is expected to begin in early 2023. We will be closely monitoring the situation and will continue to review our approach and adjust as necessary to minimise supply disruptions and regulatory burden. In the absence of any certification extensions, MDD certification lapses will need to be notified to the TGA within 60 days.
If you notified the Devices Verification Team prior to the lapses in conformity notification form being available, we will be in touch with you, there is no need to re-notify.
There is no mechanism in the Act to grant consent to supply medical devices that were not manufactured with a valid conformity assessment certificate in force at the time of manufacture. Consent to apply applications are applicable to known breaches of the Essential Principles only.
Devices manufactured after an MDD certificate has expired and prior to the MDR certification being issued are not able to be supplied in Australia. Sponsors could consider cancelling or having the ARTG entry suspended supplying the product using the SAS pathway. However, devices manufactured while the MDD certificate was valid can be supplied for 12 months after expiry.
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.
There is no legislative provision which underpins the market notification process. In recognition of the scale of the EU MDR transition, and in the interest of minimising regulatory burden on the industry, the TGA is undertaking a risk-based approach in streamlining the type of actions sponsors can undertake in meeting their obligations to notify their customers about important changes to their medical devices.
For low-risk changes that qualify for streamlined market notifications, sponsors can notify their customers about changes to their medical devices, maintain documentation to confirm that the notifications have occurred and provide this documentation to the TGA upon request.
Sponsors do not need to submit these as separate recall notifications to the TGA Recalls Section. If however, the TGA has concerns that a market notification was ineffective or done without satisfying the published eligibility criteria, the TGA could ask the sponsor to initiate a recall action following the URPTG or the TGA could mandate the recall under the existing provisions in the Therapeutic Goods Act 1989, if required.
If the EU MDD Design certification is required to support the entry ARTG as per the 2018 Determination, then yes, you must notify the TGA using the lapse in certification form.
The ACCC does not need to be advised of MDD to MDR ‘market notifications’ and the TGA has not interacted with the ACCC in developing this process. Sponsors only need to advise the ACCC of safety related recalls for ‘therapeutic goods’ which also meet the definition of ‘consumer goods’ in the Australian Consumer Law.
EUDAMED is a part of the EU MDR/IVDR implementation but is not a requirement under the Australian medical device framework.
It is expected that basic changes to the logo would not require CTS unless there is a change in the manufacturer address. If additional warnings are now required, old stock without those warnings would be considered in breach of EP 13.3 and possibly 13.4, Item 5 which states “any warnings restrictions, or precautions that should be taken in relation to the use of the device.
This is so that sponsors can inform their customers / end users of the changes which have occurred as part of the MDD to MDR transition. If sponsors answer ‘yes’ to each of the six eligibility criteria, this can be done as a streamlined market notification rather than a recall action.
Yes
The TGA is implementing the Australian UDI system which comprises changes to the Australian regulatory framework and implementation of the Australian UDI database (AusUDID).
Implementation of the Australian UDI system will be phased with voluntary compliance expected from 1 May 2023, followed by specific dates on which compliance is mandatory. These mandatory compliance dates will start with high risk and implantable medical devices and run through to the other lower classes of devices, based on risk classification.
More information on the intent of the Australian UDI system and implementation timeframes can be found in Consultation Paper 3 - UDI consultation paper 3 - Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework.
Yes, the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 outlines the evidence requirements for devices by classification. If you hold evidence from a higher classification, that is acceptable.
Yes, the MDSAP route can be used, or any pathway outlined in the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
Sponsors are required to notify the TGA of lapsing/suspended/revoked/cancelled conformity assessment certification within 60 days. There are civil and criminal penalties that could be applied if a Sponsor fails to notify the TGA of the lapsed certificate.
This question raises the differences in recall terminology between Australia and the EU. This is not applicable to the MDD to MDR Transition arrangements which is providing a “market notification” pathway for sponsors to utilise without having to submit notifications to the Recalls Section.
Proposed changes to recall terminology have been addressed in the soon to be released Discussion Paper which has been developed as part of the TGA’s Recall Reforms Program. This is a different package of work to the MDD to MDR Transition work.
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.
Devices manufactured after an MDD certificate has expired and prior to the MDR certification being issued are not able to be supplied in Australia. Sponsors could consider cancelling or having the ARTG entry suspended and supplying the product using the SAS pathway.
No, you have met the notification requirements.
If there is a lapse in certification, then yes, you are required to notify the TGA. If there is no lapse, then no you do not need to notify the TGA using the lapse in conformity assessment certification notification.
An accessory to a medical device is a medical device and the classification of the accessory is determined based on the intended purpose of the accessory, and classification rules outlined in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
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.
If the classification of the device has changed under the Australian regulatory framework, then a new application of inclusion is required. If the kind of device remains the same, then there is no need to lodge a new application of inclusion and the changes can be updated using a device change request or variation application. If the MDR certification does not change the kind of device, then a more straightforward pathway is for the sponsor to update their existing ARTG entry.
Consent to supply is required for any devices that are in breach of the essential principles if the Sponsor wants to import, supply or export in/from Australia.
In consultation with stakeholders, the TGA determines how best medical devices are regulated in Australia. In the case of the MDD to MDR Transition, the TGA considers it very important that the end users of medical devices are made aware of changes which affect the safe and appropriate use of the products.
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.
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. Please refer to the requirements for your device based on the risk classification.
The Sponsor would need to notify the TGA using the lapsed conformity assessment certification notification form. The TGA will then assess whether or not to take regulatory action on the ARTG entry. If the ARTG entry remains active, the Sponsor can continue to supply products that was manufactured prior to the CE expiry.
Sponsors are expected to cease supply within 12 months of their MDD certification expiry if they do not hold any valid certification thereafter. There is no mechanism in the Act to grant consent to supply medical devices that were not manufactured with a valid conformity assessment certificate in force at the time of manufacture. Consent to supply is not the correct pathway in this scenario.
On 29 September 2022, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect to introduce fee concessions. The concessions reduce the regulatory costs for sponsors of ARTG entry(s) supported by EU MDD/IVDD certifications transitioning to the EU MDR/IVDR and who are seeking consent to import, supply, or export their devices where they do not have compliant information to be provided with their medical devices (EP13).
The application fee for consent has been reduced to a flat $30 per ARTG entry where the application is made solely in relation to non-compliance with EP 13 (information supplied by the manufacturer) and the non-compliance is due to transitioning from EU MDD/IVDD to EU MDR/IVDR certification. This fee reduction will be applied retrospectively to applications made from 1 January 2022 (i.e.: a refund will be provided for the difference in fees where a higher fee has already been paid by eligible sponsors). Standard fees apply for consent applications where the medical device does not comply with any other Essential Principle(s).
Sponsors who qualify for a fee refund do not need to take any action. The TGA will identify eligible sponsors and issue refunds in the coming weeks.
Note: For consent applications related to other Essential Principles (different, or in addition to EP 13) or who are not transitioning to the EU MDR/IVDR, the normal processing fees of $500 for the first, and $100 for each subsequent ARTG entry/Application for Inclusion applies.
The TGA regulates medical devices that are for import into, supply in, and export from Australia. You may wish to seek advice from a regulatory affairs consultant for MDR certification requirements.
The Sponsor should notify the TGA as soon as possible and provide an explanation of why it was missed. You should also provide supply numbers of devices that were manufactured and supplied without valid conformity assessment certification.
Sponsors with an approved consent application for an ARTG entry that has been reclassified should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application and ARTG entries. You do not need to reapply for consent. The TGA will provide you with an approval for the new ARTG entry for the same approved duration.
The TGA is actively monitoring and assessing the impacts of supply shortages across all devices. Supply issues are not limited to the transition of MDD to MDR certification.
A consent to supply application can be submitted for the non-compliant device in order to continue supply, however devices that are non-compliant with the Essential Principles cannot be supplied until consent is granted by the TGA. The TGA cannot guarantee that consent would be approved prior to a DCR being approved.
If there is another conformity assessment evidence to support the ARTG entry, no notification for lapse of MDD is then required as the ARTG is supported using alternative evidence. However, we encourage you to keep the ARTG up to date and linked to the new certification.
There is no timeframe. The devices verification team will be in touch shortly.
This is so that sponsors can inform their customers / end users of the changes which have occurred as part of the MDD to MDR transition. If sponsors answer ‘yes’ to each of the six eligibility criteria, this can be done as a streamlined market notification rather than a recall action.
Yes, as long as the MDSAP certificate covers the scope of the products, and conformity assessment requirements are met for the risk classification of the device as per the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
Subject to answering ‘yes’ to each of the six eligibility criteria, an example of this would be a letter from your company to your customer base which provides sufficient details about the products which are transitioning from MDD to MDR and details about what those changes are.
The TGA cannot provide business process guidance.
No. A DCR/Variation should be completed and approved, prior to market notifications.
The SAS pathway can be used to access devices that are not supported with an ARTG entry. For users to access MDD inventory using the SAS pathway, the ARTG would need to be cancelled or suspended.
The consent to supply pathway is used to grant consent for sponsors to supply devices manufactured using the MDD certificate that do not comply with the EP’s if the devices are already supported by an ARTG entry.
The TGA is in the process of preparing guidance for EU IVDR transition and is currently working towards finalisation of the document by the first quarter of 2023. This guidance will assist manufacturers, Australian sponsors, and agents of in vitro diagnostic (IVD) medical devices included in the Australian Register of Therapeutic Goods (ARTG), where the conformity assessment certification that supports the inclusion in the ARTG is transitioning to the new certification issued under the European Union In Vitro Diagnostic Regulation (EU IVDR).
This is a sponsor/business decision. You will need to notify the TGA within 60 days of the MDD certification expiry and are expected to cease supply within 12 months of MDD certification expiry if there are no valid certification thereafter.
New applications of inclusion will be required, with appropriate evidence of conformity as outlined in the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
End users / hospitals etc can access the information about the market notification process we have published on our website, but it remains the sponsor’s responsibility to advise their customer base about changes to their own products.
As per section 41MA and 41MAA of the Therapeutic Goods Act 1989, there are civil and criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles. You only need CTS to supply devices that are no longer compliant with the EP’s. If your ARTG entry is amended, you should assess your old stock to decide if it is now in breach of essential principles if you wish to import, supply or export the device.
No, any new application of inclusion will need to be lodged at the correct classification. The reclassification transitional arrangement is only for existing ARTG entries.
The time to review and provide a decision for consent to supply relies heavily on the information provided by the Sponsor in the application. If the Sponsor provides sufficient information for the Delegate to assess the risk of the breached essential principle and a sufficient mitigation/implantation plan to show how the risk is being managed, then CTS only takes 5 days from date of payment being received. The TGA is confident they can handle the potential volume of requests.
There is currently a two month wait for an application to be reviewed. The approval timeline varies and depends on factors such as the complexity of the change and the quality and completeness of supporting information.
If a label change is not MDR related, it needs to be notified to the TGA and assessed as part of our normal processes. The type of change will determine if a recall action or other type of action is required.
Devices need to be compliant with the EP’s at the time of import/supply or export in/from Australia. As per section 41MA and 41MAA of the Therapeutic Goods Act 1989, there are civil and criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles.
Market notifications utilising the TGA’s EU MDR Transition web publication service is available from 1 December 2022. Alternatively, sponsors can also achieve this by notifying health care providers and end users directly and hold the evidence that this has been done. For changes already in effect, sponsors are advised to inform health care providers and end users of the changes, if notifications are not already in place.
Yes, and depending upon how the six eligibility criteria are answered, will determine whether the changes can be notified to your customers as a market notification or as a new recall action.
We do not have special provisions for instruments/capital equipment. 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. Legally supplied devices are not expected to be removed from the market.
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.
If both versions meet Australian EPs, both versions can be manufactured if valid certification is in place. Sponsors can supply both versions but must notify us within 60 days of the certification lapsing or expiring, and if requested, be able to provide evidence (e.g., clinical evidence) that the devices comply with all EPs.
We do not have special provisions for instruments/capital equipment. 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. Legally supplied devices are not expected to be removed from the market.
The examples of non-compliance in the presentation relates to non-compliance against EP13 (for labelling), and EP14 (for clinical evidence).
Yes. Sponsors are required to notify us within 60 days of the EU MDD 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.
We do not have special provisions for instruments/capital equipment. 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. Legally supplied devices do not need to be removed from the user after May 2025.
Yes, sponsors 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.