The European Medical Device Regulation (EU MDR) is drastically changing the regulatory framework for medical devices. One of the new major challenges is the increased focus on clinical evidence and Post-Market (or Marketing) Surveillance (PMS).
From now on, medical device companies are forced to focus more on gathering clinical and safety-related data says Emergo in a recently published article. This increases the strain on operations and affects the cost of research and development and market access. Post-Market (Marketing) Surveillance will become a very important part of the healthcare approval process for any CE-certified medical device, which will require manufacturers to understand and execute on a new and relatively complex process. To make it easier, we've created an overview of everything you need to know right here.
But why has medical device PMS become such an integral part of the regulatory framework? And why should we embrace the EU MDR Post-Market Surveillance requirements for medical devices rather than question them?
A couple of years ago, a European breast implant manufacturer was sanctioned for selling non-medical grade implants. It created a global health scare. More than 30.000 women were recommended to remove their implants and many suffered serious health problems and even death. It is believed that this case was one of the main drivers behind the increased focus on PMS in the MDR - and it might have been. However, if you look at the size of the industry and the number of devices available, the risk of a similar case re-occurring is significant.
In a recently published Netflix documentary, called "The Bleeding Edge", a filmmaker examines exactly this. The film reveals disturbing cases where people have endured serious health issues that are thought to be linked to various medical devices. The validity of the information presented in the film can be discussed, but the message that it delivers is strong.
The film touches upon different aspects of the regulatory framework. But its focus is on the market approval process and the lack of data used to support clinical efficacy and safety.
The fact is, that most devices (in the EU and USA) have been approved for marketing by solely proving 'equivalence' to a prior legally marketed device - without having to necessarily illustrate long-term clinical efficacy or safety.
This has been a standard process for market approval for a long time. However, the term 'equivalence', can be somewhat misleading. Especially when you look at the number of devices that have been approved through this process and how far back the original approval goes.
In principle, by proving 'equivalence', you are not necessarily demonstrating the clinical efficacy or safety of the new device directly. But rather demonstrating that the new device in question is 'equivalent' to the predicate device. This means that a new device that might not follow the same design, look, or be composed of the same materials, could be marketed to provide the same clinical efficacy and safety as the predicate device.
The problem with this process is that medical technology is not that simple.
The process of demonstrating ‘equivalence’, might have been fitting when medical technology was less advanced. But with the latest developments in engineering, mechanics, biomaterials, etc. devices have become more complex and designed more towards the individual rather than the general public.
Even though equivalence can be demonstrated somehow, it doesn't prove that a device will behave in the same way for all patients, or be able to provide the same benefits or safety. Especially if no scientifically valid evidence is provided to back it up.
With the ever-growing pace of development in MedTech, it can be difficult for regulators to keep up with the industry. But it's clear that the EU acknowledged that something had to change, in order to minimize the risks of new safety issues.
So, why is Post-Market (Marketing) Surveillance of medical devices important?
It is difficult to state that by removing the 'equivalence rule' and replacing it with a more strict clinical-trial requirement (similar to the pharmaceutical industry), we could have safer or more effective devices.
But, it looks like EU regulators have agreed that the issue is not necessarily related to the approval process, but rather the lack of data to support the claims - especially in the long run.
This is where Post-Market surveillance comes into play. Post-Market Surveillance is designed distinguish faulty devices on the market from those that are safe and effective. With more data comes more evidence, and with more evidence, we are less likely to allow unsafe devices to stay on the market - thereby improving the quality of treatment.
Additionally, the PMS data can give manufacturers of safe medical devices a clear-cut competitive advantage over any unsafe devices that may be on the market. Moving forward, it will be significantly harder to maintain healthcare approval if the safety and performance of a device cannot be continuously validated in real life environments. Furthermore, with easy access to information, healthcare professionals and consumers are making informed choices based on references, data and reviews. Therefore, it is likely that healthcare actors (and consumers) will choose medical devices that have the necessary evidence to support their claims, which will positively affect sales and the success of these devices. Thus, the outcome of Post-Market (Marketing) Surveillance of medical devices may be positive for both the industry and the public in the long term, and should be embraced rather than questioned.
However, the process of collecting this data can be costly, which might explain why some MedTech companies have been reluctant in conducting clinical trials or rigorous Post-Market Surveillance activities. This is especially true for companies with little or no previous experience with post-market data collection and management. Planning and executing PMS without prior experience can be very complex and end up being an extremely costly affair. Additionally, PMS data may be deemed insufficient or unusable by Notified Bodies if the PMS plan and data gathering methods are not correct.
We always recommend medical device companies to use a pre-validated EDC to ensure that data is gathered and managed in a compliant manner. SMART-TRIAL offers expert advice on medical device PMS activities as well as an industry-leading EDC Platform.
Only time will tell if more data and medical device PMS is the best way to go. But if you look at the advances in the industry, and you compare it to what’s been happening in the pharma industry for the past 20 years, it might not be as bad as it currently seems.
Even though we might initially see a drop in the number of devices, it doesn’t diminish the fact that we have to think about safety of patients. This is exactly why the industry should see this as a positive development towards better healthcare and not just a hole in their checkbooks. Most importantly, manufacturers need to get past the initial (and understandable) shock of the new MDR and move forward with PMS plans. We will continuously provide helpful resources that manufacturers can use to simplify their PMS activities. Sign up for the SMART-TRIAL Newsletter to receive them directly in your inbox.
Are you having trouble navigating the EU MDR, or are you looking for more information on how to comply with the EU MDR Post-Market Surveillance requirements?
Check our Practical Guide to PMCF EU MDR Compliance for unique insights and helpful tools.
Take a look at our latest blog on How ePRO can help comply with EU MDR Post-Market Surveillance