Presented by: Xin-Lin Goh, Therapeutic Goods Administration
Presented at: Online
Presentation date: Wednesday, 7 December 2022
Presentation summary: This is the second 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 manufacturer evidence and variations to the ARTG, 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.
The TGA is still engaging with EU commission to discuss the potential Mutual Recognition Agreement (MRA) under EU 2017/745 MDR. No decision has been made at this stage.
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.
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.
Unless exempt or excluded, all medical devices must be included in the ARTG before supply in Australia. The application to include the device in the ARTG must be made to the TGA by an Australian-based entity known as the sponsor. Sponsors are legally responsible for the sale of the medical device in Australia, and have a range of obligations including:
- Ensuring the device continues to meet all regulatory requirements
- Meeting post-market obligations for the device, including reporting adverse events to the TGA
- Ensuring advertising for the device is compliant with the Therapeutic Goods Advertising Code.
For comprehensive guidance to assist with making an application to include the medical device in the ARTG, please see the medical device inclusion process.
Yes.
Where the updated Manufacturers Evidence certificate reflects the new manufacturer details, the TGA will accept a letter from either the notified body or manufacturer addressing the following:
- Reason for the name/address change
- Has the QMS changed or remained the same
- Has the legal entity changed or remained the same
The end date of the MDD certification is May 2024. There may be devices which receive MDR certification after this date. The TGA will monitor the situation and may extend the usage of the market notification system past May 2024.
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.
With the repeal of regulation 4.1 and amendments to reg 5.3, manufacturers of class III medical devices containing substances of microbial origin are no longer required to obtain TGA conformity assessment. If a new application is supported by MDD certification, it will be subjected to a mandatory audit, and an application supported by MDR certification, may be subjected to a non-mandatory audit. If the device is already on the register and there is a gap between the existing certification and the MDR certification, then sponsors must notify the TGA within 60 days of becoming aware of the certificate expiring.
They are both valid actions, though depending on the classification and risk profile, the new application for inclusion may be subjected to a non-mandatory audit. 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. However, if the classification of the device changes under the Australian framework, then a new application of inclusion will be required as it will be considered a new kind of device.
The sponsor can submit one DCR application for up to 10 ARTG entries if the change is the same for all entries.
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.
Yes, sponsors are encouraged to keep their ARTG entry up to date, including changes to the intended purpose.
An ARTG entry can only be linked to one Manufacturer Evidence. It is highly encouraged that you associate the ME that is most relevant to the ARTG entry, and hold evidence of any other ME as necessary, and be able to provide that to the TGA upon request. Please note that the additional devices must be of the same kind, and must meet requirements outlined in the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018.
Applications supported by EU MDR certification are not subjected to mandatory audits but may be subjected to non-mandatory audits. Application timelines depend on a number of factors, including the intended use and indications, quality of data submitted etc.
An ARTG entry can only be linked to one Manufacturer Evidence. Once all devices under your ARG entry have transitioned to the MDR, you can then update the ME on file to the EU MDR certificate.
No. A change in classification under the Australian medical device framework is considered to be a new kind of device and a new application of inclusion will be required.
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.
Yes. 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. Please refer to the requirements for your device based on the risk classification.
Yes, these forms are available from the eBS portal.
The GSPRs are requirements under EU Medical Device Regulation (MDR) 2017/745 and the Essential Principles are requirements under the Australian medical device framework. The TGA requires that the safety and performance characteristics of medical devices meet the Essential Principles (EPs) set in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.
A variation application form is specific to class III and AIMD only. If you wish to amend the information related to lower class devices you can submit a DCR. If the changes results in the device being of a different kind, then a new application for inclusion will be required.
These questions will allow us to monitor the transition and the analytics and reporting will allow streamlining of processes where appropriate.
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.
It is recommended that sponsors submit a variation to manufacturer evidence prior to submitting a DCR - where there has been a change to manufacturer details (legal entity and QMS are unchanged).
For a manufacturers evidence variation where the manufacturer details have changed, the sponsor will be required to submit the current conformity assessment certificate, and a letter from the notified body/manufacturer stating the reason for the change and whether or not the QMS or legal entity has changed as a result.
The TGA assessor of the DCR will review the manufacturers evidence linked to the ARTG to ensure that the ME has been updated and the supporting evidence of change is acceptable. An additional statement is not required for a DCR unless requested by the TGA.
Yes, products with MDSAP certification are not affected by the EU MDR Transition.
Medical devices have not been reclassified to medicines by our regulations although we have noted a number of medicines that have incorrectly been included in the ARTG as medical devices. We also note there may be differences in the Australian and EU framework. You can contact us for further discussion about this product and the appropriate pathway to supply.
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.
Where the updated Manufacturers Evidence certificate reflects the new manufacturer details, the TGA will accept a letter from either the notified body or manufacturer addressing the following:
- Reason for the name/address change.
- Has the QMS changed or remained the same.
- Has the legal entity changed or remained the same.
Where there has been an update to a MDD certificate after 26 May 2021, the TGA will only accept documentation from the Notified Body that indicates the change is non-significant under Article 120(3) of EU 2017/745 (MDR).
An ARTG entry can only be linked to one Manufacturer Evidence. It is highly encouraged that the sponsor associates the ME that is most relevant to the ARTG entry, and hold evidence of any other ME while under transition and be able to provide that to the TGA upon request.
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.
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.
The ME identifier is listed on the ARTG certificate.
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 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.
If the legal manufacturer changes, a new application of inclusion is required as the device is considered a new kind of device under the Australian regulatory framework.
No. If seeking to update the ME on file from EU MDD to EU MDR, 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 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.
Sponsors are encouraged to keep their ARTG entries up to date with complete and correct information. If the entry is incorrect or incomplete, then sponsors can lodge a Device Change Request application to update their entry.
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. A Device Change Request application should not be used for device reclassification and will be rejected.
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, the sponsor can choose to update the relevant ME, 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.
CE markings have no bearing under the Australian medical device framework.
Yes, if there is supporting evidence (i.e., audit report, technical report, or a letter from the Notified Body) to show that the proposed new manufacturer’s evidence, such as MDD or MDR certificate, covers the proposed product changes and the certificate is still valid.
They are both valid actions, though depending on the classification and risk profile, the new application for inclusion may be subjected to a non-mandatory audit. 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.
Which regulatory pathway a device and medicine combination product shall follow is determined by the Primary (Principal) Mode of Action (PMoA) - the mechanism of a combination product that makes the greatest contribution to the combination product’s overall intended use(s).
If a combination product achieves its PMoA via its mechanical property, not by pharmacological, immunological, or metabolic means, it is regulated as a medical device that shall follow medical device guidance (i.e., ARGMD). However, if it achieves its PMoA by pharmacological, chemical, immunological, or metabolic means in or on the body of a human, the guidance relevant to medicines (i.e., ARGPM or ARGCM) applies.
Applicants are strongly encouraged to email the TGA at DCAS@health.gov.au prior to submitting an application for a TGA Conformity Assessment Certificate to discuss the characteristics and intended use of their product and to ascertain the TGA’s requirements.
No. An ARTG entry can only be linked to one Manufacturer Evidence. It is highly encouraged that you associate the ME that is most relevant to the ARTG entry, and hold evidence of any other ME as necessary, and be able to provide that to the TGA upon request.
Our mailbox is EUMDRTransition@health.gov.au
If the device’s classification is also changing under the Australian medical device framework, then a new application of inclusion will be required as the device is considered to be a new kind of device.
No. Manufacturers and sponsors should select the GMDN code that is most appropriate for their device when lodging an application with the TGA.
This is not a problem. 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. Sponsors can hold multiple conformity assessment documents, however only one can be linked to the ARTG entry.
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. Please refer to the requirements for your device based on the risk classification.
If the device’s classification is also changing under the Australian medical device framework, then a new application of inclusion will be required as the device is considered to be a new kind of device.
All entries apart from class I non-sterile non-measuring, if supported by EU MDD certification, will be affected by the EU MDR transition, unless seeking alternative conformity assessment pathways (e.g. MDSAP).
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.
Yes, sponsors holding TGA CAC are not affected by the EU MDR transition.
On 29 September 2022 and 20 December 2022, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect to introduce fee concessions for consent to supply and device change requests respectively.
For consent to supply a medical device that does not comply with Essential Principle 13, the fee is $30 for each ARTG entry seeking Consent to Supply, and is to be applied retrospectively (ie: a refund for the difference in fees where a higher fee has already been paid by eligible sponsors) to applications that were made from 1 January 2022. Standard fees apply for Consent to Supply a medical device that does not comply with any other Essential Principle(s).
For an application to vary an ARTG entry for a medical device, where the only change is to update the manufacturer evidence identifier to reflect the new EU MDR, EU IVDR or MDSAP certificate, the fee is reduced from $482 to $190 per application and can include up to 10 ARTG entries if the change to be applied to all entries is the same (i.e. updating to the same manufacturer evidence identifier).
The proposed fee reductions for both consent to supply and device change requests are retrospective, and refunds will be organised for the difference in fees where the 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), and for device change requests or variations to the ARTG for any other change types, such as a change to the intended purpose.
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.
You must notify the TGA within 60 days of the certification being revoked. You cannot continue to supply the devices that have been manufactured after a certificate has been revoked if you do not hold any other valid certification.
Notification of conformity certification expiry should be done using the Lapses in medical device conformity assessment certification notification form
If you have already notified the Devices Verification Team via email – they will be in touch with you.
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 Lapses in medical device conformity assessment certification notification form
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. Therefore, 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.
The Devices Verification Team will be in touch with you if you notified them prior to the lapsed notification form being available. There is no need to re-notify.
We do not have a special approach for 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.
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.
The TGA is working on aligning our GMDN code table with that of the GMDN agency. At times, discrepancies arise. If a sponsor encounters an issue, please get in Email us for assistance.
The TGA holds an ME repository, and new ME applications which are submitted are not associated with any ARTG applications or entries. The association is formed only when the sponsor lodges an application for inclusion, and selects the relevant ME, or when the sponsor submits a DCR to request that the new ME is linked to their ARTG entry. If the sponsor is updating their ME on file through an ME variation application (e.g., updating from MDD to MDR certificate), then there is no need for a DCR to de/relink the ME as the ME on file will be updated with the new ME, and the linkage is already there with the relevant ARTG entries.
If the scope of the MDR certificate covers the devices in the ARTG entry, and there are no other changes as a result of transitioning from the MDD to the MDR, then the sponsor can update their ME to reflect the new MDR certificate. No other action is required.
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. Therefore, sponsors should keep their documentation in relation to the conformity assessment certification pathway that is being utilised to support their ARTG inclusion up to date.
Section 41FDB of the Act relating to the preliminary assessment of applications requires that the application be made in accordance with the form approved, in writing, by the Secretary for that classification of medical device, and that if the application has not passed preliminary assessment, the Secretary must refuse the application.
If the device name is listed in the ARTG, then a DCR should be submitted to ensure that the information on the ARTG is complete and correct. Sponsors are encouraged to ensure that the changes are approved prior to supply.
We will consider developing one for future updates of our guidance material.