This is part two of MBIP’s series on Medical Device Regulations and IP.
Part 1 defined of what constitutes a medical device, touched on regulatory frameworks across Australia, the US and Europe, and introduced the Medical Device Lifecycle. It also included discussion of the first stage in the lifecycle: Concept & Early feasibility. In Part 2, we will discuss stage 2 of the lifecycle in depth: Pre-Market Submissions.
2. Pre-Market Submissions
US
In the US, there are three tiers to the classification system which categorises a medical device based on its risk:
- Class I (low risk), may include devices such as examination gloves and bandages.
- Class II (moderate risk), may include devices such as infusion pumps, surgical lasers and powered wheelchairs.
- Class III (High risk) may include implants such as pacemakers and devices that support or sustain life.
In terms of classifying low and moderate risk medical devices, the preferred pathway to market in the US is through the 510(k) pathway. A 510(k) is a pre-market submission demonstrating to the FDA that the device to be marketed is safe and effective, that is, “substantially equivalent to a legally marketed device”, which if successful, leads to the device being cleared for market. The assessment for a device being substantially equivalent involves considering if the compared devices have the same intended use and technological characteristics, including factors such as their designs, mode of operation, materials and energy use. The 501(k) pathway is generally the simplest and fastest classification pathway.
For classifying higher risk devices (Class III), the premarket approval (PMA) application pathway is primarily used before the medical device can be legally marketed. This is a more complex process compared with the 501(k) pathway, since it involves a comprehensive review of scientific and clinical data to prove safety and efficacy of the device.
There is also the De Novo classification pathway, which is an intermediary between a 510(k) submission and a PMA application, in that there is no substantially equivalent technology that the device could be compared to. A successful De Novo classification results in the medical device being classified as a Class I or II device.
A medical device that has been successfully classified under the De Novo pathway can assist competitors with subsequent devices having the same intended use to enter the market, since the newly classified De Novo device can in turn be used as a comparator for other “substantially equivalent” devices that are seeking to enter the market. However, it could also raise barriers to entry for other competitors, as De Novo Applicant may have a first-mover advantage in that they can file submissions to the FDA arguing that the data complied for the De Novo pathway involves establishing a certain level of performance standard to ensure the safety and efficacy of the device. Thus, comparable clinical studies must be performed in all subsequently filed 510(k) submissions in the same classification. This strategy of using a De Novo classification to raise barriers to market entry is particularly powerful for Software as a medical device product. For example, if the software is a machine learning algorithm, the De Novo Applicant having the largest compiled dataset could argue that a similarly sized dataset would be required to ensure algorithm accuracy, which would make it especially difficult for subsequent software medical devices to enter the market.
Europe
In Europe, there is a four-tier classification system based on device invasiveness, duration of contact as well as the potential risk of the device in question.
- Class I (Low risk) e.g. non-invasive instruments and bandages
- Class IIa (Low-to-moderate risk) e.g. some dental devices and hearing aids
- Class IIb (Moderate-to-high risk) e.g. infusion pumps and ventilators
- Class III (High risk) e.g. implants or devices for delivering medical substances
The premarket regulatory process in Europe differs from that of the US. Europe uses the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for conducting conformity assessments, with Notified Bodies acting as independent verifiers for manufacturing compliance.
Whilst the approval process is more decentralised in Europe, using Notified Bodies, the approach is more standardised across the risk classifications, with higher-risk devices undergoing more rigorous and comprehensive assessment. Lower risk devices (Class I) need only be “self-declared” that they conform with the Essential Requirements to the national Competent Authority in their country of origin. In the UK, the Competent Authority is the Medicines and Healthcare Products Regulatory Agency (MHRA).
Crucially, the difference between approval of a medical device in the US when compared with Europe is that a device must be shown to be both safe and efficacious in the US, whereas in Europe, approved medical devices only need to prove safety and performance. In other words, how the device performs, or how the device will likely perform based on predicates rather than clinical trials, is the focus of the approval process in Europe, which does not require a demonstration of clinical efficacy.
Given that approval of medical devices in the US occurs via a centralised body (the FDA) the approval process is much slower than that in Europe. Thus, device approval applications rarely receive approval at the same time in Europe and in the US, even if the applications were filed at the same time. Typically, the approval process in the US is 3 years slower than in Europe for high-risk devices. For lower risk devices, the gap in timeframe for approval between the two jurisdictions is much shorter. Nevertheless, when considering the overall timeframe for bringing the device to market, both the US and the EU have similar timeframes, as approvals in Europe must be followed by reimbursement approval before the device can become available for patient use.
Australia
Classification of medical devices in Australia follows the same system as in Europe, having four classes: Class I (low risk), Class IIa (low to moderate risk), Class IIb (Moderate to High risk) and Class III (high risk).
In Australia, premarket approval involves undergoing a structured process as regulated by the TGA. The first part of this process is to determine the classification of medical devices. This depends on their risks to patients, and in turn determines the level of regulatory control required for their approval and ongoing monitoring.
For low-risk devices (Class I) these require a self-declaration that the compliance requirements are met to ensure safety and performance of the device. There is no formal assessment of these low-risk devices prior to listing on the ARTG.
Low-to-moderate-risk devices (Class IIa) require a Conformity Assessment be carried out by the manufacturer or an accredited conformity assessment body, as recognised by the TGA, to prove compliance with the relevant standards before listing on the ARTG.
Higher risk devices (Class IIb) undergo the same Conformity Assessment as Class IIa devices, but further require a detailed review of technical documentation, clinical data and evidence of any risk management practices in place.
Medical devices in the highest risk category undergo a more detailed Conformity Assessment, which includes a comprehensive evaluation of clinical data, a review of the technical documentation and details of how post-market surveillance is to be carried out.
The Australian framework for manufacturers to demonstrate safety and performance of their medical device relies on a set of regulatory requirements known as the Essential Principles. The Essential Principles are relevant for applications concerning device registration in Classes IIa, IIb and III, and outlines the requirements and standards to be used for the manufacturing processes, it also outlines design specifications of the device and requires details to be provided on risk management practices.
These Essential Principles must be adhered to by manufacturers, with compliance being demonstrated through documentation and third-party evaluations, where required.
Once the TGA is satisfied that the application meets all criteria, the medical device is granted approval and is listed on the ARTG, which then allows the device to be legally marked and distributed in Australia.
Classification of Medical Devices Affects IP Strategy
Classification is a critical aspect of the regulatory process for medical devices as it directly affects the process of how a company navigates the regulatory requirements and the claim strategy used for protecting the device. Specifically, higher-risk devices (Class III (FDA) and Classes IIb/III (EU/AU)) typically require greater technical detail in the specification, as regulators require more extensive validation and clinical evidence. This often affects claim strategy, as it leads to a narrower claim scope as Examiners look towards whether or not the claim scope is enabled and supported by the examples and evidence as provided in the specification. On the other hand, lower-risk devices (Classes I/II (FDA) and Classes I/IIa (EU/AU)) typically have broader claim scope encompassing a number of embodiments, since regulatory controls are less stringent for these types of devices.
This also means that there may be greater likelihood that companies developing higher-risk devices (Class III (FDA) and Classes IIb/III (EU/AU)), will require one or more divisional applications in the longer term.
It is important to revisit the claim scope at the end of the premarket stage to ensure that the final approved medical device configuration is aligned with the intended commercial scope, so to avoid competitors exploiting the invention. Furthermore, whilst regulatory submissions are usually confidential in nature, post-approval summaries may become public information, which emphasizes the importance of ensuring all relevant patent applications are filed prior to receiving approval for the medical device.
The next part in this article series will discuss the next stages in the Medical Device Life Cycle: Market Entry and Post-Market Surveillance & Iteration.
In the meantime, if you have any questions about the IP strategy during the process of creating a medical device and getting it classified, please reach out to our team.
