Proposed delayed commencement of certain Medical Device Regulatory Changes
During recent months, the world has been focusing on their emergency response to the Covid-19 pandemic, while Manufacturers were still expected to implement transitional arrangements to the new Medical Device and In-Vitro Diagnosis Regulations released globally.
Australia is no exception to the rule and a number of regulatory changes described in the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 were initially planned to come into effect between January and August of this rather eventful year…
On 16 June 2020, the TGA announced a proposed delay in the implementation of the reforms up to November 2021. This delay would provide a well justified relief for industry, healthcare professionals and the TGA.
Make sure you keep track of the main changes and their implementation dates:
Reclassification of devices
A good place to start is to discuss device re-classifications. Medical Device Regulations and Regulatory oversight (i.e. Conformity Assessment Procedures) are based on the classification of a device according to the risk associated with its use. A change in your device classification can therefore have a significant impact on your marketing plans and on the expected technical data (e.g. clinical evidence requirements).
The following devices are being up-classified:
- Spinal Implantable Medical Devices (some will move from Class IIb to Class III)
- Active Medical Devices for therapy with diagnostic function (from Class IIa/b to Class III)
- Active Implantables (from AIMD to Class III)
- Devices administering a medicine or biological by inhalation (From Class I/IIa to IIa/b)
- Medical Devices that consist of substances introduced into the body via a body orifice or applied to the skin (from Class I/IIa, now up to Class III)
- Medical Devices in direct contact with the heart, central circulatory or central nervous system (Class IIa to Class III)
This up-classification, which was to come into effect on the 25 August 2020, is now proposed to be delayed until 25 November 2021.
Devices already on the ARTG or for which an application is made prior to the deadline may qualify for special transitional arrangements until 2024.
Software as Medical Devices (SaMDs)
Advancements and widespread software technologies are being progressively accommodated by Regulators around the world. Most notably was in 2017 within the new EU MDR (2017/745) which provided more relevant (i.e. non-physical) classification rules and pathways for Medical Device Software in Europe.
Whilst both the EU and AU follow the broader recommendations set by IMDRF, there are some differences in local applications between the two regions. In March 2020, the TGA also published some additional guidance on legislated definitions that appear in their Regulation.
As per the current amendments, new applications for ARTG inclusions of SaMD would need to follow the new ruling from 25 August 2020. TGA has however, now proposed a new transition date of 25 February 2021. Transitional provisions are also in place for legacy devices.
Personalised Medical Devices
When commercially available mass-produced medical devices are unable to meet the needs of certain clinical cases, healthcare providers may produce or provide specifications to a manufacturer to make, personalised or custom-made devices.
As there are significant differences in the way custom-made medical devices are regulated in comparison to other medical devices and as new technologies become available (e.g. additive manufacturing), there was an increasing risk that a range of distributed medical devices do not fit in the existing regulatory framework.
New reforms have been a couple of years in the making, with the introduction of a new “notification scheme” in 2016, formal requests for information (refer our July 2017 blog) in 2017 and a range of consultations through to 2019.
Regulatory changes are now being formally introduced, these include:
- Clarification of definitions, which in most cases will result in a narrower scope of exemption from ARTG entry for devices which were previously deemed “custom-made”
- Changes in requirements for “custom-made” devices, including:
- New annual reporting requirements to the TGA for supplied custom devices;
- Possible TGA inspections of the custom-device production facilities (regardless of the exemptions, this is another good reason for implementing a good QMS);
- Specific record retention periods of at least five years for non-implantable and 15 years for implantable custom-devices; and
- Provision of information about the custom device to the intended recipient.
Also worth noting are:
- new concepts and frameworks for “Medical Device Production Systems” which are essentially the manufacturing tools that produce custom devices (e.g. 3D printer) and which may now become regulated Medical Devices in their own right; and
- an update to Classification rule 5.4 (X-Ray films and panels) under which Anatomical models and other equivalent “imaging mechanisms” will now be classified as a Medical Device Class IIa (typically a bump from Class I) and subject to the relevant conformity assessment procedure.
Whilst current amendments indicate a transition date of 25 August 2020, the new proposed implementation date is set for 25 February 2021. There are also some transitional arrangements for devices which may be subject to a re-classification.
IVD Companion Diagnostics
Following TGA consultations through 2018-2019, the amended regulations now include new definitions for “IVD companion diagnostic”. The definition provides closer alignment with other major jurisdictions such as the EU and US:
“IVD companion diagnostic means an IVD medical device:
(a) that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:
- to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or
- to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or
- to monitor the individual’s response to the use of a particular medicine or biological; and
(b) that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and
(c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual—that is not intended by the manufacturer to be used for the examination of the specimen merely to determine whether the medicine or biological is compatible with the individual.”
Since 1 February 2020, applications for inclusion of an IVD companion diagnostic in the ARTG are subject to a mandatory application audit under amendments at subparagraph 5.3(1)(j)(x).
A TGA Guidance on Regulatory Requirements was published in February 2020 to provide additional information to manufacturer on classifications, IFUs, conformity assessment procedures and most importantly transitional arrangements for applications made before the cut-off date or devices already included on the ARTG.
Further information about the reforms will continue to be published, with the TGA working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months. Keep an eye on our blogs and webinars for any relevant updates!
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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